DRUG SAFETY ASSOCIATE (PSMF & BUSINESS SUPPORT) - ZURICH

Ort: Switzerland - Glattbrugg/Zurich

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 (PSMF & Business Support) to join our Drug Safety Team. Reporting directly to the Head Drug Safety Alliance Management, you will be responsible to manage Vifor Pharma’s EU- and other regional and local PSMFs, including quarterly updates of core text and annexes. Your tasks and responsibilities will include, but not be limited to, the following:
  • Manage the regular updates of the EU- and other regional and local Pharmacovigilance System Master File (PSMF)s.
  • Establish a global PSMF strategy for Vifor Pharma.
  • Collaborate with Vifor Regulatory, Medical and Global Business organisations to develop and employ local solutions to meet country- and region-specific PSMF and QPPV requirements.
  • Liaise with stakeholders from multiple departments and locations to obtain PSMF inputs.
  • Manage PSMF submissions as required within and outside of EU.
  • Liaison with local/regional QPPVs for maintenance of the contractual framework, access to PV information and oversight
  • Support the Vifor Pharma Business Organisation to negotiate and conclude Safety Agreements for new business situations.
  • Support the Vifor Legal Department to negotiate and conclude confidentiality and service agreements/work orders with e.g. external consultant companies and CROs.
  • Support the IT Department to manage software licence and service agreements with vendors of the IT applications in use at Global Drug Safety.
  • Liaise with Global Drug Safety functions and other Vifor Departments to find solutions to support local PV operations.
  • Liaise with Affiliates and Partners and with Vifor functions within and outside of Global Drug Safety to negotiate terms of Safety Agreements, according to corresponding procedures and using the approved document templates.
  • Other projects on assignment.
The ideal candidates is holding a university degree in pharmacovigilance / pharmacology / medicine / healthcare / other life sciences or business administration / law in addition to the following experience:
  • Minimum of 2 years working experience in pharmacovigilance at a pharmaceutical company or CRO, preferably including experience in post marketing surveillance / drug safety operations and PSMF management
  • Good knowledge of pharmacovigilance regulations (GVP, FDA), prefrably good knowledge of worldwide/regional/local pharmacovigilance regulations (Emerging Markets, MEA or CIS/RU experience preferred)
  • Fluency in English, French or Spanish are a plus
  • Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Experience in management of safety data exchange agreements, clinical trial agreements, quality agreements or similar specialist pharmaceutical or medical device industry agreements preferred
  • Experience in management of external consultants preferred
You bring good interpersonal skills with a problem and conflict solving attitude. You have strong communication skills orally and in writing and good analytical skills. You are organised in your approach, with a good sense for prioritisation and the identification of critical situations from a drug safety perspective. You work effectively in cross-functional teams, with the ability to develop good working relationships with service providers and global partners.

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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