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23.10.2019

Deputy EU QPPV - Europe

  • Germany - Munich
  • Vollzeitstelle

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.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Deputy EU QPPV - Europe

Location: Germany - Munich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
Kira Maurer
International Talent Acquisition Specialist
+41 58 851 83 48
Apply
Agency policy
About you

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 organisations
  • Reports of safety issues and concerns to Vifor Pharma Group Senior Management (dotted reporting line to the Chief Medical Officer) as appropriate
  • Support / advise in the context of Pharmacovigilance Inspections
  • Review 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 documents
  • Being 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 activities
  • Ensure international regulatory intelligence screening
  • Access to and responsible for the maintenance of the PV system master file (PSMF) and Global Regulatory Affairs support for PSMF-like requests
  • Health authority inspection participation
  • Ensure 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 qualification
  • Demonstrated experience in most areas pertaining to Pharmacovigilance and Pharmacovigilance Legislation (EU GVP)
  • Ability to efficiently and productively communicate in English orally and in writing
  • Demonstrated ability to accurately and effectively evaluate, interpret and present data contained in medical / scientific literature as well as relevant for study design and conduct
  • Understanding of medical aspects in therapeutic areas relevant for Vifor Pharma, along with willingness to develop in-depth expertise
  • Organisational excellence and project management skills
  • Must be based in the EEA
  • Ability to travel to Vifor Pharma Operational Headquarters in Switzerland
You 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.
 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

Apply
Agency policy

Deputy EU QPPV - Europe

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 organisations
  • Reports of safety issues and concerns to Vifor Pharma Group Senior Management (dotted reporting line to the Chief Medical Officer) as appropriate
  • Support / advise in the context of Pharmacovigilance Inspections
  • Review 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 documents
  • Being 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 activities
  • Ensure international regulatory intelligence screening
  • Access to and responsible for the maintenance of the PV system master file (PSMF) and Global Regulatory Affairs support for PSMF-like requests
  • Health authority inspection participation
  • Ensure 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 qualification
  • Demonstrated experience in most areas pertaining to Pharmacovigilance and Pharmacovigilance Legislation (EU GVP)
  • Ability to efficiently and productively communicate in English orally and in writing
  • Demonstrated ability to accurately and effectively evaluate, interpret and present data contained in medical / scientific literature as well as relevant for study design and conduct
  • Understanding of medical aspects in therapeutic areas relevant for Vifor Pharma, along with willingness to develop in-depth expertise
  • Organisational excellence and project management skills
  • Must be based in the EEA
  • Ability to travel to Vifor Pharma Operational Headquarters in Switzerland
You 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.
Vifor Pharma
Drug Safety/Pharmacovigilance

Arbeitsort:

Germany - Munich

Kira Maurer
International Talent Acquisition Specialist
+41 58 851 83 48