DRUG SAFETY ASSOCIATE - EUROPE

Ort: Spain - Barcelona

Funktion: Drug Safety/Pharmacovigilance

Firma: Vifor Pharma

Georgia Izzat

International Talent Acquisition Specialist

+41 58 851 83 78

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Ihr Profil

We are currently looking for a Drug Safety Associate to join our Drug Safety Team. Reporting directly to the Head of Drug Safety Hub, you will be responsible to manage and process safety reports between European Vifor Pharma affiliates, Vifor Fresenius Medical Care Renal Pharma affiliates and Global Drug Safety. You will be assigned as main responsible for some of the affiliates and your  tasks and responsibilities will include, but not be limited to, the following:

  • Receipt, tracking and triage of safety reports
  • Translation of reports into English before sharing with Global Drug Safety team
  • Coordination and/or conducting of routine follow-up activities in countries
  • Tracking of inbound and outbound communication related to individual safety cases
  • Coordination of case reconciliation with affiliates
  • Compliance metrics of reporting to Global Drug Safety
  • Development and maintenance of Drug Safety training materials
  • Conducting and tracking of trainings for affiliate staff
  • Liaising with Medical Affairs compliance to create and update Procedural Documents
  • Participating as Subject Matter Expert in audits and inspections at the affiliates
  • Implementation and ensuring timely closure of CAPAs and support affiliates with CAPA management
  • Streamlining processes and compliance with Global Drug Safety team
  • Maintaining close  collaboration with different sources of safety reports such as Quality Assurance, Medical Information and Special Program Responsible

The ideal candidates is holding a university degree in pharmacovigilance or life sciences field in addition to the following experience:

  • 1-2 years working experience in Drug Safety including experience in post marketing surveillance / drug safety operations
  • Fluency in English, French and one additional language (Dutch, Spanish, Italian and/or German)
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Experience in drug safety database, preferably ARISg is preferred
  • Experience in trainings, audits and inspections is preferred

The role will be based either at one of our European affiliates or at the Operational Headquarter in Zurich.

You have strong communication skills orally and in writing and good analytical skills. You are organised and accurate in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You are able to maintain good working relationships with affiliates and head quarter employees, work effectively in cross-functional teams. You work in line with the Vifor Pharma values.

Über uns

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.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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