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Vifor Pharma

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Vifor Pharma

Flughofstrasse 61
8152 Glattbrugg

23.10.2019

Vifor Pharma

Deputy EU QPPV - Europe

  • Vifor Pharma

  • Germany - Munich

  • 23.10.2019

  • Vollzeitstelle

We are currently looking for a Deputy EU/EEA  Qualified Person for Pharmacovigilance (EU QPPV) to be situated in one of our Europe affiliate (preferrably Germany, Netherlands or Sweden) to support and directly report to the EU QPPV and support the Drug Safety and Risk Management team as a whole. In accordance with current relevant EU/EEA pharmacovigilance directives the EU QPPV oversees all benefit – risk balance activities related to products licensed in the EU/EEA for which Vifor Pharma Group is registered as MAH in the therapeutic areas nephrology, cardio-renal and iron deficiency. In addition, the Deputy EU QPPV will have an active role to promote, maintain and improve compliance with the legal requirements without the necessary accountability for the execution of the various activities. The Deputy EU QPPV needs to have full oversight of the PV system and its related quality management system in order to function as back-up of the EU QPPV or act as the EU QPPV during his/her absence. Your tasks will include, but not be limited to:Oversee functioning of the pharmacovigilance system in all relevant aspects and secure consistency and compliance with European legislation, including: Quality Control and Assurance procedures, SOPs, Aggregate Safety reports, database operations, contractual arrangements, compliance data, audit reports, and PV training of personnel, including EU country organisationsReports of safety issues and concerns to Vifor Pharma Group Senior Management (dotted reporting line to the Chief Medical Officer) as appropriateSupport / advise in the context of Pharmacovigilance InspectionsReview and sign off PSURs/RMPs for medicinal products for which Vifor Pharma holds marketing authorisations in accordance with EU requirements and receive copies of other signed off pharmacovigilance documentsBeing involved in the review of protocol and study report and sign-off of protocols of post-authorisation safety studies (PASS) conducted in the EU Being aware of and involved in the implementation of risk minimisation activitiesEnsure international regulatory intelligence screeningAccess to and responsible for the maintenance of the PV system master file (PSMF) and Global Regulatory Affairs support for PSMF-like requestsHealth authority inspection participationEnsure Health Authority Liaison, Global Liaison, and Country Safety Liaison The ideal candidates is holding an MD or PHD in the Life Sciences field in addition to the following experience: Medical Doctor (preferred),  Biologist or Pharmacist, PhD  Minimum 5 years’ work experience in PV functions, documented training and proof of appropriate qualificationDemonstrated experience in most areas pertaining to Pharmacovigilance and Pharmacovigilance Legislation (EU GVP)Ability to efficiently and productively communicate in English orally and in writingDemonstrated ability to accurately and effectively evaluate, interpret and present data contained in medical / scientific literature as well as relevant for study design and conductUnderstanding of medical aspects in therapeutic areas relevant for Vifor Pharma, along with willingness to develop in-depth expertiseOrganisational excellence and project management skillsMust be based in the EEAAbility to travel to Vifor Pharma Operational Headquarters in SwitzerlandYou demonstrate strong communication and relationship building skills and can therefore work effectively in cross-functional teams. You have outstanding analytical skills and display strong organizational as well as time management skills. You have broad scientific and medical knowledge with continuous expansion and learning ability.
Inserat ansehen

18.10.2019

Vifor Pharma

Project Manager CDD (h/f) – Suisse

  • Vifor Pharma

  • Switzerland - Field based

  • 18.10.2019

  • Vollzeitstelle

Afin de soutenir le succès de notre filiale Suisse, nous recherchons un/e Project Manager pour une durée de 15 mois. A ce poste, vous rapportez directement au Directeur Marketing et êtes en charge du déploiement et implémentation d’un projet stratégique « Projet de Laboratoire » sur l’ensemble de la Suisse. Vous travaillez généralement 4 jours sur le terrain et 1 jour au bureau. Vos missions principales sont les suivantes :Gérer et développer dans les détails le " Projet de laboratoire "Construire des relations et le réseau avec les laboratoires, les fournisseurs en diagnostique, les associations politiques, les formateurs et les agences IT LabImpliquer les décideurs des laboratoires dans le projet, lancer des activités pour en démontrer la valeur ajoutée Guider et soutenir les laboratoires dans leurs efforts visant à fournir des rapports différenciésSoutenir les laboratoires dans leurs communications avec les prescripteurs en ce qui concerne les changements dans les rapports et l’offre d’analyses Étudier la possibilité d'élargir le projet pour que les laboratoires reçoivent des demandes avec indication de la part de la part des prescripteursSurveiller l'impact des changements mis en œuvre (rapports de laboratoire, recommandations)Participer au congrès respectifsGérer le budget consacré au projetPour mener à bien cette mission, nous recherchons une personne structurée dotée d’un esprit entrepreneurial amenant le profil suivant :Diplôme universitaire (master ou bachelor) en Economie, Sciences, Médecine ou avec CFC laborantin/eExpérience en Marketing, Ventes ou en Affaires MédicalesAu moins 3 ans d’expérience en milieu Pharmaceutique, Laboratoires ou Medical DevicesExpérience préalable en gestion de projetsDe langue maternelle française ou allemande, avec de bonnes connaissances de l’autre langue. Des connaissances en anglais sont un plusVous vous décrivez comme une personne capable de travailler efficacement tant de manière autonome qu’en équipe. Grâce à votre sens aigu de l’analyse et votre excellente communication, vous pouvez aisément convaincre vos interlocuteurs vers un objectif commun. Vous êtes une personne orientée clients et résultats, qui souhaite être moteur de changement dans une entreprise.Si vous recherchez une entreprise innovante et agile où vous pourrez concrètement laisser votre empreinte, n’hésitez pas à postuler.
Inserat ansehen

18.10.2019

Vifor Pharma

Project Manager Befristet (m/w) - Schweiz

  • Vifor Pharma

  • Switzerland - Field based

  • 18.10.2019

  • Vollzeitstelle

Um den Erfolg unserer Schweizer Tochtergesellschaft zu unterstützen, suchen wir einen/e Projektleiter/in für einen Zeitraum von 15 Monaten. In dieser Position berichten Sie direkt an den Marketing Director und sind für den Einsatz und die Umsetzung eines strategischen Projekts "Laborprojekt" verantwortlich. Sie arbeiten in der Regel 4 Tage im Feld und 1 Tag im Büro. Ihre Hauptmissionen sind wie folgt:Leitung und Entwicklung des "Laborprojektes" im DetailAufbau von Beziehungen und Netzwerken zu Labors, Diagnostika-Anbietern, politischen Verbänden, Fortbildungsspezialisten und IT-LaboragenturenLaborentscheider in das Projekt einbeziehen, Aktivitäten starten, um den Mehrwert zu demonstrierenFührung und Unterstützung der Laboratorien bei ihren Bemühungen, eine differenzierte Berichterstattung zu ermöglichenUnterstützung der Labors bei der Kommunikation mit den Verordnern bezüglich Anpassungen der Laborberichte und bzgl. dem LaborangebotskatalogErkundung der Möglichkeit, das Projekt so zu erweitern, dass Labors bei Bestellungen durch den Arzt Angaben zur Indikation vornehmenÜberwachung der KPIs für die umgesetzten Änderungen (Laborberichte, Empfehlungen)Teilnahme an laborspezifischen KongressenVerwaltung des ProjektbudgetsFür die Umsetzung dieser Mission suchen wir eine strukturierte Person mit Unternehmergeist, die das folgende Profil mitbringt:Hochschulabschluss (Master oder Bachelor) in Wirtschaft, Wissenschaft, Medizin oder Ausbildung als Laborant (CFC)Erfahrung in den Bereichen Marketing, Vertrieb oder Medical AffairsMindestens 3 Jahre Erfahrung in der pharmazeutischen Industrie, in Laboren bzw. in der Medical Device IndustrieErfahrungen im ProjektmanagementMuttersprache Französisch oder Deutsch, mit guten Kenntnissen der anderen Sprache. Englischkenntnisse sind von VorteilSie beschreiben sich selbst als eine Person, die sowohl alleine als auch im Team sehr effizient arbeitet. Dank Ihrem analytischen Scharfsinn und überzeugenden Kommunikation nehmen Sie Einfluss auf Mitarbeiter aller Ebenen, um die Vorstellung für das gemeinsame Ziel zu bilden und zu pflegen. Sie sind ergebnis- und kundenorientiert und möchten eine treibende Kraft des Wandels sein. Wenn Sie nach einem innovativen und agilen Unternehmen suchen, in dem Sie Ihre Spuren konkret hinterlassen können, zögern Sie nicht, sich zu bewerben
Inserat ansehen

12.10.2019

Vifor Pharma

Field Medical Advisor – Region Eastern Switzerland

  • Vifor Pharma

  • Switzerland - Field based

  • 12.10.2019

  • Vollzeitstelle

Due to the expansion of our global business, we are looking for new medical affairs team members with a field focus working as Field Medical Advisor to develop the Eastern Region of Switzerland. In this function, you represent Medical Affairs externally; establishing and maintaining medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of Vifor Pharma Group. You develop and execute the country medical plan, through scientific engagement with the medical community. You are responsible for the following tasks:Develop and maintain scientific and medical expertise (Cardiology and Nephrology and corresponding products)Identify, develop and maintain relationships with KOLs, HCPs and professional organizationsKOL scientific engagement, key account medical support, training and medical information Update medical team and other internal stakeholders on medical community interactions Provide medical support to market access activities following global and local policies and proceduresSupport the development, implementation and completion of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs)Provide Disease State Education, clinical presentations and respond to medical requestsServe as a medical resource for internal medical and sales trainingSupport company sponsored clinical research and IIS process Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations or symposiumEnsure compliance with applicable local and global laws, regulations, guidelines and company policies and proceduresDevelop personal and professional capabilities to improve skills and professional capabilitiesWe are looking for an experienced and enthusiastic candidate bringing the following profile:Master or PhD in Scientific Field (e.g. Pharmacy, Medicine, biochemistry or Biology)Minimum of 3 years’ experience in clinical practice, research or pharmaceutical medical affairsMinimum of 5 years’ experience with pharmaceutical industry and healthcare compliance requirements locally and globallyPrevious experience as Field Medical Advisor or Medical Scientific Liaison is preferredExperience in therapeutic area(s) Cardiology and/or Nephrology is a plusDemonstrated experience in KOL, HCP or medical community engagementExcellent oral and written communication skills in German and very good oral and written communication skills in English. Knowledge in French is an assetYou live in the region you work for and enjoy working field based with customers Willingness to travel for international congresses and/or boarder country congresses Your ability to work well within a team ensures your success within a collaborative environment. Your expert medical knowledge enables your ability to establish and maintain strong relationships with KOLs and other key stakeholders. You are a positive, solution-driven and result-oriented person that likes to work in an entrepreneurial environment, where you can make the difference.
Inserat ansehen

12.10.2019

Vifor Pharma

Field Medical Advisor – Region Middle Switzerland

  • Vifor Pharma

  • Switzerland - Field based

  • 12.10.2019

  • Vollzeitstelle

Due to the expansion of our global business, we are looking for new medical affairs team members with a field focus working as Field Medical Advisor to develop the Middle Region of Switzerland. In this function, you represent Medical Affairs externally; establishing and maintaining medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of Vifor Pharma Group. You develop and execute the country medical plan, through scientific engagement with the medical community. You are responsible for the following tasks:Develop and maintain scientific and medical expertise (Cardiology and Nephrology and corresponding products)Identify, develop and maintain relationships with KOLs, HCPs and professional organizationsKOL scientific engagement, key account medical support, training and medical information Update medical team and other internal stakeholders on medical community interactions Provide medical support to market access activities following global and local policies and proceduresSupport the development, implementation and completion of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs)Provide Disease State Education, clinical presentations and respond to medical requestsServe as a medical resource for internal medical and sales trainingSupport company sponsored clinical research and IIS process Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations or symposiumEnsure compliance with applicable local and global laws, regulations, guidelines and company policies and proceduresDevelop personal and professional capabilities to improve skills and professional capabilitiesWe are looking for an experienced and enthusiastic candidate bringing the following profile:Master or PhD in Scientific Field (e.g. Pharmacy, Medicine, biochemistry or Biology)Minimum of 3 years’ experience in clinical practice, research or pharmaceutical medical affairsMinimum of 5 years’ experience with pharmaceutical industry and healthcare compliance requirements locally and globallyPrevious experience as Field Medical Advisor or Medical Scientific Liaison is preferredExperience in therapeutic area(s) Cardiology and/or Nephrology is a plusDemonstrated experience in KOL, HCP or medical community engagementExcellent oral and written communication skills in German and very good oral and written communication skills in English. Knowledge in French is an assetYou live in the region you work for and enjoy working field based with customers Willingness to travel for international congresses and/or boarder country congresses Your ability to work well within a team ensures your success within a collaborative environment. Your expert medical knowledge enables your ability to establish and maintain strong relationships with KOLs and other key stakeholders. You are a positive, solution-driven and result-oriented person that likes to work in an entrepreneurial environment, where you can make the difference.
Inserat ansehen

22.10.2019

Vifor Pharma

Operational Lead Business Operations (limited contract) – Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 22.10.2019

  • Vollzeitstelle

We are seeking an Operational Lead for our Marketing and Market Access functions, to provide operational leadership to the Chief Business Officer (CBO). This role will be based at our office in Glattbrugg, Zurich, and report directly to the Chief Business Officer.  Your tasks will include, but not be limited to, the following:• Act as the senior point of contact for CBO Leadership Team, in alignment with Marketing, Commercial, Market Access, liaising with GCO leadership team and other executive committee members • Oversee and lead all Business Operations operational activities and ensure efficiency, simplicity and executional focus across the team and for dedicated GBTs• Lead annual Brand Planning and Strategic Planning Process, globally across brands and as well as operationally across all Business Operations functions • Lead CBO Brand finance and budget planning process• Lead CBO business cases• Provide leadership support and change management• Coordinate and communicate between all CBO extended functions and internal partners • Establish and ensure an effective and streamlined communication across all GBTs towards internal and external stakeholders• Support the CBO Leadership Team in goal setting, performance management, potential management and development planningThe ideal candidate brings an MBA or equivalent education, in addition to the following experience:• Minimum of 6 years of experience in a Project  Management role within the pharmaceutical industry and/or consulting Industry, preferably in an international environment• Strong pharma background• Fluency in English, German or French language skills will be an asset• Strong analytical skills • Financial knowledge on P&L• Outstanding communication, interpersonal and presentation skills coupled with experience interacting with C-suite and board level executives• Ability to conceptualize and create executive level presentations • Experience in a PMO or Chief of Staff function is be strongly preferredYou demonstrate entrepreneurial and commercial thinking, with the ability to formulate strategies and concepts in creative and innovative ways. You lead effectively across a matrix organisation, with the ability to decide and initiate action. You have outstanding communication and interpersonal skills. You work in line with the Vifor Pharma values. 
Inserat ansehen

14.10.2019

Vifor Pharma

Therapeutic Area Lead - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 14.10.2019

  • Vollzeitstelle

We are currently looking for a Therapeutic Area lead to join our Global Drug Safety and Risk Management Team. In this leadership role you will be reporting directly to the Global Head of Medical and Clinical Drug Safety, you will be responsible to ensure the scientific foundation of the Benefit-Risk profile of our products as well as the compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following:Manage the review of worldwide reports on adverse events including confirming company causality assessmentsManage the timely authoring of high quality aggregate safety reports Support the Regulatory department with evaluation of adverse event profiles of products to update regulatory documentsSupport and deliver safety trainings for new staff, pharmacovigilance staff as well as refreshersImplementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc. Ensure safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms, unblinding) are handled appropriately and in compliance with regulationsProvide support in checking or preparing expert reports as appropriate and preparing safety regulatory filesSignal detection and benefit/risk evaluation including initiating appropriate measures e.g. preparing safety board presentations, change control of SmPC, updating risk management plan and resulting actions plansActive involvement in PASS or other safety studiesCreation/authoring of Medical / Clinical Safety related SOPsThe ideal candidate holds an M.D. degree in addition to the following experience: Medical Degree, ideally clinical experience as Specialist in Internal Medicine, Cardiology or Nephrology or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safetyExperience with Benefit-Risk profile process implementation and monitoring Experience in leading a team of Drug Safety Physicians or Scientists or proven line management experienceExperience in data analysis, signal management and Benefit-Risk evaluation for at least 5 yearsExcellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)Fluency in EnglishExperience in Pharmaceutical Medicine development, particularly Clinical Research, Clinical Pharmacology, and PharmacoepidemiologyDemonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues for both post-marketing medicines as well as medicines in clinical development (particularly dossier submission). Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issuesExperience with Health Authority inspections (EMA, FDA, other) Good computer literacy with experience with safety data bases (Aris G preferably) and IT affinityCapable of exercising oversight in professional communications and problem solving liaisons with internal and external customers at senior level Capable of exercising oversight in the understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety developmentExperience of or capable of lecturing at international drug safety conferencesYou bring very good scientific, pharmaceutical and medical knowledge. You have excellent verbal and written communication skills as well as demonstrated leadership skills and are able to become quickly a valued and esteemed senior member of our interdisciplinary teams. You are able to build and maintain good relationships with a strong customer focus.  You will professionally and successfully represent the company on the Benefit-Risk related matters in front of Health Authorities or other important external organisations or events. Your attitude and behaviour is congruent with the company values. You show concern for standard and take a thorough approach, with high attention to detail. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. You are effectively able to plan and prioritise workload, with an accurate sense of urgency. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude and build a well-functioning team with high quality output in good team spirit.
Inserat ansehen

02.10.2019

Vifor Pharma

IT Security Expert - Architecture and Operations - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 02.10.2019

  • Vollzeitstelle

We are seeking an IT security professional who will be based at our operational headquarters in Zurich. Responsible for continuous improvement of Group security landscape and reduction of security risk exposure. Providing technical security consultancy and requirements to projects and internal stakeholders. Advising and supporting the business and IT in implementing IT security requirements and promoting desired behavior in regard to security awareness through trainings etc. Reporting directly to the IT Security Officer, your tasks and responsibilities will include, but not be limited to, the following:Define security requirements and review of IT projects and architecturesReview and support the enhancement of security policies, standards and proceduresAssess security risks and identify appropriate mitigation actionsPerform internal technical security verifications, assessments, and threat huntingProvide incident response / support to IT teams during security incidents. Investigate suspected security incidents, recommend and coordinate corrective actionsProvide on-call services when needed for incidentsCollaborate and negotiate effectively with external partners and perform vendor risk assessmentsSupport the continuous security monitoring and protection of IT systemsParticipate in the development, operations, and improvement of security technologies, related tools and processesContribute to security reports, dashboards and alerts to create an overall situational awareness of the threats Assist in the review of applications and/or technology environments acquisition and/or procurement of new applications or technologiesOwnership of IT security operation projects to further develop security systems (e.g. security monitoring, data leakage prevention, network security)The ideal candidate is an IT Security professional with the following essentials skills and experience:A degree in Security/IT/Engineering or relevant experienceRecognised professional security certification (e.g.: SSCP, CISSP, GIAC) or comparable experienceProven experience in Security Operation analysis, identifying, monitoring and controlling with at least 3 years on hands-on security incident handling and coordinationExcellent knowledge of securing IT infrastructure with respect to information security concernsDemonstrated experience in IT security architectures design and assessmentsDeep knowledge of IT security in areas such as system security, incident response, forensics, security monitoring management, and application securityKnowledge and experience with Information Security Frameworks (e.g.: ISO27001, NIST) and best practices in security engineering: network security, security operations, systems security, policies, and incident responseFluent level in English (in oral and written communication)The following skills would be advantageous:Experience as pentester Negotiation and project management skills Knowledge of regulated environments (GxP) Additional languages You have excellent analytical and problem-solving skills, hands-on working style, reliable, autonomous, proactive, solution oriented mindset, team player fostering good working atmosphere and showing a strong interest in information security. You are strong in communicating complex and sensitive topics on both, business and technical staff levels. You have very good networking skills and a broad professional network. You have understanding of business requirements and technology to support business objectives. You are able to work on different projects and activities simultaneously. You act as a role model for others in line with Vifor Pharma values.
Inserat ansehen

01.10.2019

Vifor Pharma

Time Management Specialist - 80 - 100% – Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 01.10.2019

  • Vollzeitstelle

We are looking for a Time Management Specialist to join our HR team at our Operational HQ in Glattbrugg, Zurich. Reporting directly to the Head of Global Compensation and Benefits and HR Shared Services, you will be responsible for all tasks related to time management, administration and tracking. Your tasks and responsibilities will include, but not be limited to:Time administrator for designated populationSet up of new hires, calculate any changes affecting time tracking (e.g. unpaid leave, sickness, changing work schedules), and overseeing the termination processEntering absences as needed, in coordination with HR Operations and Payroll (e.g. time keeping for long term sickness)Training of HR administrators and usersAct as single point of contact for time and attendance enquiries (including business partner enquiries)Inform employees of data mismatches or wrong data entryProvide ad-hoc reporting Ensure complianceEnsure consistency in administration of policies and practicesSupport time and absence related projectsReview processes and provide input for efficiency gainsIn this role we will need a team player who is self-motivated and intellectually curious. In addition you will bring the following:Commercial degree or educationFurther education in HR or social insurance is a plusAt least one year of experience in an HR function, preferably as a time administratorAdvanced Excel skills are highly desirableBusiness level in English and German (written and spoken)Knowledge of French and is a plusYou are flexible and adaptable with a service-oriented approach. You are precise in your work with high attention to detail, ensuring reliability to deliver on all required tasks. You are able to manage priorities effectively and remain organised in a fast-changing environment. You are solution-oriented and think in an entrepreneurial way.
Inserat ansehen

28.08.2019

Vifor Pharma

Drug Safety Lead - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 28.08.2019

  • Vollzeitstelle

We are currently looking for a Drug Safety Lead to join our Global Drug Safety and Risk Management Team. Reporting directly to the Therapeutic Area Lead of Medical and Clinical Drug Safety, you will be responsible to ensure compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following:Manage the review of worldwide reports on adverse events including confirming company causality assessmentsManage the timely authoring of high quality aggregate safety reports Support the Regulatory department with evaluation of adverse event profiles of products to update regulatory documentsSupport safety trainings for new staff, pharmacovigilance staff as well as refreshersImplementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc. Ensure safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulationsProvide support in checking or preparing expert reports as appropriate and preparing safety regulatory filesSignal detection and benefit/risk evaluation including initiating appropriate measures e.g. preparing safety board presentations, change control of SmPC, updating risk management plan and resulting actions plansActive involvement in PASS or other safety studiesCreation/authoring of Medical / Clinical Safety related SOPsThe ideal candidates holds an M.D. degree in addition to the following experience: Medical Degree, ideally Specialist in Internal Medicine or Pharmaceutical Medicine / PhD or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safetyOr Pharma experience with university background with link to health care or patient health and scientific interest Experience in data analysis, signal detection and benefit/risk evaluationExcellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)Fluency in EnglishExperience in Pharmaceutical Medicine, particularly Clinical Research, Clinical Pharmacology, and PharmacoepidemiologyDemonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issuesDemonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issuesGood computer literacy with experience with safety data bases (Aris G preferably)Capable of exercising oversight in communications and problem solving liaisons with internal and external customersCapable of exercising oversight in the understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety developmentYou bring very good scientific, pharmaceutical and medical knowledge. Your positive, optimistic attitude and behaviour is congruent with the company values. You show concern for standard and take a thorough approach, with high attention to detail. You can think and influence conceptually, strategically and rationally. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. You are able to actively participate and contribute to an interdisciplinary team. You have excellent verbal and written communication skills. Affinity to IT would be an advantage. You are effectively able to plan and prioritise workload, with an accurate sense of urgency. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.
Inserat ansehen

22.10.2019

Vifor Pharma

Chemielaborant/in Analytische Entwicklung – St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 22.10.2019

  • Vollzeitstelle

In Ihrer Position als Chemielaborant/in Analytische Entwicklung sind Sie verantwortlich für die Entwicklung und Validierung analytischer Methoden, die Qualifizierung analytischer Geräte und die Erhebung von analytischen Daten. In dieser Rolle werden Sie direkt an den Chemiker Analytische Entwicklung berichten. Dabei erfüllen Sie folgende Aufgaben:Entwicklung neuer Methoden, Verbesserung bestehender Methoden und Validierung unter Verwendung verschiedener Analysetechniken, z.B. ICP-OES-, GPC-, IC / LC-, GC-MS-, IR- und UV / VIS-SpektrometerDurchführung von Routineanalytik im Bereich Forschung und Entwicklung Unterhalt und Betreuung der Geräte als Geräteverantwortliche gemäss aktueller Liste der GeräteverantwortlichenEinhaltung der GMP-Richtlinien im ArbeitsbereichBefolgung technischer, organisatorischer und personeller SicherheitsmassnahmenFür diese Stelle suchen wir nach einer belastbaren und professionellen Persönlichkeit mit folgendem Profil:Abgeschlossene Lehre als Chemielaborant/in, idealerweise spezialisiert auf analytische Methoden zur PolymercharakterisierungErfahrung im Bereich der Instrumentellen Analytik Mehrjährige Erfahrung in der Entwicklung neuer Analysemethoden Fliessende Deutschkenntnisse in Wort und Schrift, gute Englischkenntnisse Sicherer Umgang mit MS Office Programmen und LC Software wie ChromeleonFlexibilität, sich rasch auf neue Projekte/Fragestellungen einstellen zu könnenÜbersicht bewahren, wenn an mehreren Projekten gleichzeitig gearbeitet wirdSie sind eine zuverlässige und flexible Persönlichkeit, die gerne im Team arbeitet und Verantwortung für die eigene Arbeit übernimmt. Zudem verfügen Sie über sehr gute Kommunikationsfähigkeiten und schätzen die Teamarbeit.
Inserat ansehen

20.10.2019

Vifor Pharma

SAP Stammdatenspezialist (Operations) - St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 20.10.2019

  • Vollzeitstelle

Derzeit suchen wir einen SAP Stammdatenspezialist für unser Finance-Team in St. Gallen. In dieser Rolle rapportieren Sie direkt an den Teamleiter Accounting und sind für das Anlegen sowie für die Pflege von Lieferanten- und Kundenstammdaten innerhalb von SAP verantwortlich. Im Weiteren gehört die Unterstützung des Buchhaltungsteams am Standort St. Gallen in administrativen Bereichen zu Ihren weiteren Aufgaben.Ihre Tätigkeiten umfassen:Kunden- und Lieferantenstammdaten anlegen und pflegen:Sammeln und Validieren der Daten, die zur Erstellung und Pflege der Kunden- und Lieferantenstammdaten erforderlich sind Verarbeiten, Aktualisieren der neu erstellten und bereits bestehenden Kunden- und LieferantenstammdatenEffizientes Verarbeiten der Kunden- und Lieferantenstammdaten-AnfragenMitwirken an ProzessverbesserungenProjektunterstützung:Unterstützung bei Ad-hoc-Massnahmen zur Massenerstellung oder -änderung von Kunden- und Lieferantenstammdaten Mögliche Unterstützung in SAP-Rollouts, Geschäftsprozessänderungen oder anderen ProjektarbeitenErmitteln von Möglichkeiten zur Datenbereinigung und Erhöhung der DatenqualitätZusätzliche Aufgaben:Kontinuierliche Qualitätssteigerung in SAP im Zusammenhang mit Kunden- und LieferantenstammdatenUnterstützung des Accounting Teams für Dokumentenarchivierung in SAP, Versand von Lieferantenrechnungen und ablegen von BuchhaltungsbelegenWeitere administrative Arbeiten möglichSie verfügen über eine ausgeprägte Kommunikationsfähigkeit und die Fähigkeit, erfolgreich mit verschiedenen Standorten, Funktionen und Interessengruppen zu arbeiten. Dazu bringen Sie einen hohen Teamgeist mit sich. Sie zeigen Eigeninitiative, sind unternehmerisch und ergebnisorientiert. Sie verfügen über ein hohes Mass an Genauigkeit und bewegen sich gerne innerhalb eines dynamischen und lebendigen Umfeldes. Ausserdem bringen Sie folgende Erfahrungen mit:1-2 Jahre ERP-Stammdatenpflege mit Schwerpunkt Kunden- und LieferantenstammdatenErfahrung in der Arbeit mit SAP ist bevorzugtFähigkeit und Bereitschaft, eine erhebliche Anzahl von Anfragen und Transaktionen zu sammeln, zu organisieren und zu verarbeitenMicrosoft Excel und Office SuiteEinfache Anpassung an sich ändernde Umgebungen und SystemverbesserungenDetailorientierung und GenauigkeitVerhandlungssicheres Deutsch und Englisch, schriftlich und mündlich
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04.10.2019

Vifor Pharma

IT Business Analyst / Application Specialist – St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 04.10.2019

  • Vollzeitstelle

We are seeking an IT Business Analyst / Application Specialist who will be based at Vifor (International) AG in St. Gallen and will ensure that the main applications LIMS and Chromeleon in the laboratory are available, stable and secure. In this role, the person will report to the to the Head of Business IT Applications and will be part of the Global Business Application Management team. The person will be responsible for the following tasks:Support and operate the LIMS and Chromeleon application Monitor applications operating parameters for unusual events, processes or access problemsWork closely together with the Suppliers, Subject Matter Experts and Business to implement new workflows, applications or to resolve any type of problemSupport on the 2nd and 3rd level IT support serviceEnsure that all services delivered are optimal and cost effectiveEnsure the availability of the applications and the related servicesManage on-going maintenance of systems and documentationEnsure compliance with all Vifor Pharma policies, and official laws and regulationsCoordination and technical lead of IT projects, creation of IT conceptsRisk analysis and implementation of changes and bug fixesDo IT-Pikett activities on weekly basis or support them during working hours and be available for planned maintenance on weekendsThe ideal candidate is an Information Technology professional with the following essentials skills and experience:Minimum 5 years of experience in IT role, preferably as Business Analyst or Application Specialist/ Application ManagerMinimum 3 years of experience in application management in the pharmaceutical industry with knowledge of pharmaceutical regulatory guidelines for computer System validation (CSV, GAMP, FDA 21 CFR Part 11, PIC, etc.) or equivalent qualification from another regulated industry (e.g. banking)Experience with laboratory systems in pharmacySound technical understanding of relevant application including configuration, customisation, administration, interfaces, etc.Professional knowledge for Microsoft Windows ServerVery good knowledge of SQL/Oracle databases and SQL scriptingUnderstanding of basic backup and recovery proceduresProficiency in use of MS Office products (e.g. Excel, PowerPoint)Fluency in EnglishThe following skills would be advantageous:Experience in LIMS (iCD as an asset) and laboratory environmentsExperience in Chromeleon (Empower)Experience in ERP (e.g. InforXA, SAP)Experience with iCD (Admin Training, Reporting)Knowledge and experience of Jaspersoft StudioITIL CerificationGerman and French would be advantageous For this role, we are looking for a proactive candidate who demonstrates entrepreneurial approach and can drive the necessary activities to bring our infrastructure and services to the next level. Being in that role will allow to underline the necessary «can do» attitude, team player spirit and act as a role model for others in line with Vifor Pharma values.
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23.09.2019

Vifor Pharma

Technical Project Manager - St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 23.09.2019

  • Vollzeitstelle

For our Technical Project Management Team, we are currently looking for a Technical Project Manager, based at Vifor (International) AG in St. Gallen. In this function you report directly to the Technical Project Brand Lead within Technical Operations. You will be responsible for managing interdisciplinary projects across all Vifor Pharma organisation. Your responsibilities will include but will not be limited to:Driving and closing of projects according to agreed timelinesEnsuring development and introduction of new/adapted processes/products as according to the objectives and corporate management planningRepresentation of the technical aspects in cross functional committeesFollow and implement state-of-the-art project management standards and tools fit for purposeEngage and maintain appropriate stakeholder management throughout the life cycle of your projectsContact with the external principal/s and selected service providers and contract manufacturing organizationsThe ideal candidate is bringing a degree in natural/life sciences or an associated engineering degree (i.e. Biology, Biochemistry, Chemistry, Pharmaceutics, etc.), in addition to the following experience:Project Management experience with a deep technical understandingExperience in the management of interdisciplinary projects in an international environment, including working with international companies and contractorsExperience in the pharmaceutical or chemical industry, ideally with an understanding of pharmaceutical manufacturing processes, CMC and GMP requirements Strong analytical thinking skillsFluency in English both verbally and in written, German language is an advantageYou are self-motivated Project Manager who brings advanced communication and negotiation capabilities. You describe yourself as a resilient and responsible person with distinctive teamwork skills. Your analytical mindset and your practice-oriented way of working ensure that you always have an overview and a pragmatic solution even in hectic situations. You are a role model for others in terms of the Vifor Pharma Values and continuously display a positive can-do attitude.
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18.10.2019

Vifor Pharma

Apprenti Laborantin en Chimie (h/f) 100% - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 18.10.2019

  • Vollzeitstelle

A ce poste, vous avez l’occasion de débuter en août 2020 la formation d’apprenti(e) laborantin(e) en chimie durant 3 ans sur notre site de production à Villars-sur-Glâne. Rattaché(e) au département qualité, vous travaillez en collaboration étroite avec le département de la production. Vos tâches seront les suivantes :Suivre la formation définie par le règlement de la brancheAppliquer les procédures et les instructions dans un environnement des bonnes pratiques de fabricationParticiper aux analyses de routine selon les instructions en vigueurAppliquer les consignes de sécuritéUtiliser les moyens informatiques usuelsAfin d’assurer au mieux cette fonction, votre profil est le suivantVous avez terminé ou terminez prochainement votre scolarité obligatoire. Une formation supérieure de type ECG reste un atout.Vous parlez couramment français et avez des connaissances en allemand et/ou anglais.Vous avez de la facilité dans les branches scientifiques.Vous êtes à l’aise sur les outils usuels informatiques.Nous recherchons une personne ayant le sens des responsabilités, un solide esprit d’équipe, l’envie d’apprendre dans un environnement dynamique, et de développer son aptitude à travailler de façon autonome. Si vous vous reconnaissez dans ce profil, nous vous remercions de nous transmettre votre candidature (CV, lettre de motivation et relevés de notes des deux derniers semestres) en cliquant sur le bouton « postuler ». Merci de prendre note que nous n’acceptons pas de candidatures postales.
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18.10.2019

Vifor Pharma

Apprenti Laborantin en Biologie (h/f) 100% - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 18.10.2019

  • Vollzeitstelle

A ce poste, vous avez l’occasion de débuter en août 2020 la formation d’apprenti(e) laborantin(e) en biologie durant 3 ans sur notre site de production à Villars-sur-Glâne. Rattaché(e) au département qualité, vous travaillez en collaboration étroite avec le département de la production. Vos tâches seront les suivantes :Suivre la formation définie par le règlement de la brancheAppliquer les procédures et les instructions dans un environnement des bonnes pratiques de fabricationParticiper aux analyses de routine selon les instructions en vigueurAppliquer les consignes de sécuritéUtiliser les moyens informatiques usuels Afin d’assurer au mieux cette fonction, votre profil est le suivantVous avez terminé ou terminez prochainement votre scolarité obligatoire. Une formation supérieure de type ECG reste un atout.Vous parlez couramment français et avez des connaissances en allemand et/ou anglais.Vous avez de la facilité dans les branches scientifiques.Vous êtes à l’aise sur les outils usuels informatiques.Nous recherchons une personne ayant le sens des responsabilités, un solide esprit d’équipe, l’envie d’apprendre dans un environnement dynamique, et de développer son aptitude à travailler de façon autonome. Si vous vous reconnaissez dans ce profil, nous vous remercions de nous transmettre votre candidature (CV, lettre de motivation et relevés de notes des deux derniers semestres) en cliquant sur le bouton « postuler ». Merci de prendre note que nous n’acceptons pas de candidatures postales.
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12.10.2019

Vifor Pharma

Product Manager Women’s Health - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 12.10.2019

  • Vollzeitstelle

At this function, you are in charge of managing a portfolio of products in the Women’s Health Area and are responsible of their sales results on the Swiss Market. As head of the brand team you work closely with our local Medical and Sales Teams as well as with the Global Teams to ensure elaboration and effective implementation of tactical plans. Your contribution to the success of our products is key. Your main responsibilities are the following:Realization of market analysis, competitive analysis and implementation of appropriate measuresDevelopment of marketing strategies and operational implementation of activities related with your portfolio of products “Women’s Health”Elaboration of promotional material and initiation of specific projectsElaboration and management of budgetsOperational support for projects in medical and marketing areasParticipation in national and international congresses and management of KOLsClose collaboration with the Headquarters of Vifor PharmaFor this challenging position, we are looking for a person with an entrepreneurial mindset and strong analytical and conceptual skills. You bring the following profile:University degree in the scientific and/or in business area (such as Economy, Business Administration, Medicine, Pharmacy, Biology or similar)At least 4 years’ experience in pharmaceutical product managementGerman or French as mother tongue with good knowledge of the other language. Very good knowledge of English is also requiredYou describe yourself as an innovative, entrepreneurial, reliable and stress resistant person, who likes to work in interdisciplinary teams. Your excellent and convincing communication skills allow you to successfully interact with your customers both internal and external. Autonomous and objective oriented, you love to embrace new challenges and to use your team spirit to fully contribute to the development of your products’ portfolio “Women’s Health”
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11.10.2019

Vifor Pharma

Quality Assurance Specialist 100% CDD (h/f) - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 11.10.2019

  • Vollzeitstelle

Nous recherchons pour une durée de 1 an, un/e spécialiste en assurance qualité. Basé en zone de production et rattaché à la cellule “continuous Improvement, vous travaillez en étroite collaboration avec le département de production, principalement le conditionnement et garantissez la stabilité des processus et la maîtrise des coûts relatifs. Vos principales activités sont les suivantes :Gérer et suivre les non conformités initiées par le conditionnementCoordonner les investigations directement sur le terrain avec les services concernésAssurer l’établissement, la revue, l’approbation des rapports d’investigationParticiper à la définition et à l’implémentation des CAPA Assurer activement le suivi et l’implémentation des “Change Controls” qui impactent le département productionProposer et participer activement aux projets d’amélioration continue (5S, SMED)Pour mener à bien ses missions, nous recherchons une personne rigoureuse amenant le profil suivant:Formation supérieure en pharmacie, biologie, chimie ou similaire2-3 années d’expériences professionnelles dans un poste similaireDes bonnes connaissances des normes GMPDe langue maternelle française, vous possédez également de bonnes connaissances en anglais (écrites et orales) Maîtrise des outils informatiques courantsDisposé à effectuer 1x par mois un service de piquet les samedis et dimanches inclusVous vous décrivez comme une personne dotée de très bonnes compétences de communication, d’organisation et êtes orienté solution. Vous aimez travaillez de manière autonome et efficace au sein d’équipes pluridisciplinaires.
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06.10.2019

Vifor Pharma

Pharmaceutical Development Specialist 60% - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 06.10.2019

  • Vollzeitstelle

We are looking for a Pharmaceutical Development Specialist 60% for our production site in Fribourg. At this position, you work within the Pharmaceutical and Analytical Development department and are responsible for the management of pharmaceutical development projects in line with internal Vifor Pharma procedures and according to current international guidelines. Your main activities are:Formulation and packaging development as well as elaboration of suitable manufacturing processes of innovative liquid and solid dosage formsSet-up target product profile and justify product specificationsAuthor and review development, scale-up and manufacturing validation plans and reports, manufacturing instructions, risk analysis and parts of regulatory submissions to support filing.Management of complex manufacturing transfers (out- or back-sourcing)Evaluation of new raw materials or raw material changesSupport for the compilation of technical documentation for the submission of new products or variations to the authoritiesFor this interesting role, we are looking for a dynamic person with the following profile:University Degree (M.Sc.) in pharmaceutical sciences or pharmaceutical engineering – or relevant work experience in pharmaceutical processes and galenics Ideally first experience within the pharmaceutical industryAdvanced theoretical knowledge of pharmaceutical technology for solid and liquid products and knowledge of current GMP standardsFluency in English and French both in oral and written conversation. German is an asset.Mastery of common computer tools such as Ms-OfficeYou describe yourself as a rigorous, conscientious, well-organized and structured person with a strong analytical mindset. Thanks to your good communication skills, you interact easily with other departments. You are able to do your tasks autonomously while enjoying working together as part of a team.
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03.10.2019

Vifor Pharma

Marketing Trainee CDD 100% - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 03.10.2019

  • Vollzeitstelle

We are offering a paid internship of one year. At this position, you work with the marketing team for the implementation of new projects. Your tasks include:Work closely with product managers and manage marketing projects for clientsAnalyze customers, competitors and other relevant stakeholders to generate business-relevant insights and detect opportunities within marketsDefine, plan and implement marketing activities, like for example eventsDevelop ideas and content for digital and social media activitiesRespect the planned strategy and the budgetEnsure contact with HQ, customers and partnersMake sure external services have the right education regarding the productsProvide administrative support to the teamFor this role, we are searching for a team player and customer-oriented person bringing the following profile:University degree in Marketing or in the scientific area (Medicine, Pharmacy, Biology or similar)Experience or education in healthcare industry / medicine / sciences is an assetEntrepreneurial mindset Affinity for digital and social mediaAbility to work with MS-Office tools.German or French as mother tongue, with very good command in the other language and in EnglishYou are a young talented person looking for an experience in Marketing. You have entrepreneurship mindset and like to work in an autonomous way. You are able to analyze efficiently information and bring new ideas.
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25.09.2019

Vifor Pharma

Opérateur au Conditionnement Pharmaceutique 3x8 CDD (h/f) - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 25.09.2019

  • Vollzeitstelle

Suite à une hausse des demandes de production, nous renforçons nos effectifs et recherchons plusieurs opérateurs en conditionnement pour une durée de un an. Au sein du département de production, vos tâches principales consistent à assurer le conditionnement des spécialités pharmaceutiques conformes aux spécifications définies, dans le respect des normes GMP et ISO et des délais impartis. Vos responsabilités sont les suivantes :Conduire les installations de conditionnementEffectuer les changements de format, les réglages, les nettoyages, les dépannages et les maintenances de premier niveau sur les équipementsCompléter et signer toute la documentation relative au travail effectuéEtudier et proposer des solutions d’amélioration continueGarantir l’entretien du matériel, des équipements et des zones de productionAfin d’assurer les missions qui vous seront confiées, votre profil est le suivant:CFC d’opérateur sur machines automatisées ou une formation jugée équivalenteLa maîtrise de la langue française, aussi bien à l’oral qu’à l’écrit, est indispensable.Une première expérience similaire (apprentissage et/ou stage inclus) dans le secteur pharmaceutique ou agroalimentaire soumis aux normes BPF et ISONous recherchons des candidats calmes, rigoureux et capables de comprendre rapidement des processus critiques. Doté/e d’un sens de l’observation développé et d’une grande faculté d’adaptation, vous êtes une personne autonome, consciencieuse, capable de prendre des responsabilités.Intéressé/e à relever un nouveau challenge ? Alors n'hésitez pas à nous soumettre votre dossier de candidature.
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