Head of Country Pharmacovigilance Switzerland (m/f)

REFERENZNUMMER:

241341/2

IHRE AUFGABEN:

-Hold primary responsibility for all country pharmacovigilance (PV) and report directly to the Country Medical Director (CMD) with a dotted line to the respective GPV&E Regional Director/Head
-Lead and bring to resolution with all appropriate functional groups, locally (Swiss market) and globally, all product safety related issues that arise in the country
-Ensure audit readiness and lead cross-functional teams to ensure that internal and external inspections are conducted effectively
-Act as the local Swiss PV representative on the crisis management team
-Perform and document reconciliation with medical information enquires, ensuring local reconciliation with Product Quality Complaint (PQC), if required by the HA
-Ensure the timely and appropriate submission of local and foreign adverse event reports to the local Health Authority (HA) and Ethics Committees (ECs) per the local regulatory reporting requirements
-Act as a point of contact for the local HA and ECs for PV related issues, and for PV enquiries from local office, managing requests from the local HA regarding PV issues, in close liaison with Global Pharmacovigilance and Epidemiology (GPV&E) and the local Global Development and Medical Affairs (GDMA) and Global Regulatory Sciences (GRS) personnel
-Strong communication with local authorities like Swissmedic

IHRE QUALIFIKATIONEN:

-PhD in Pharma or Biotechnology
-Strong knowledge in the fields of Drug Safety and Pharmacovigilance
-Fluent in German and English, knowledge in French advantageous
-Strong experience in the pharmaceutical sector

WEITERE QUALIFIKATIONEN:

, Drug safety manager