Business Purpose
Mepha Schweiz Ltd is currently looking for a Pharmacovigilance (PV) Associate, acting as Deputy Local Safety Officer, supporting the Head of Pharmacovigilance Switzerland and Local Safety Officer (local QPPV) in maintenance of the local Pharmacovigilance System, in close collaboration with the PV cluster, regional and global Pharmacovigilance Organization of Teva Pharmaceuticals.
Your tasks
Managing the collection and processing of Adverse Events/Special Situations in compliance with local and regional regulations and the applicable company SOPs
Conducting reconciliation of safety data with other departments and partners
Supporting authority requests, signal screening and signal reporting activities
Supporting management of local SOPs and procedures, including writing the documents
Organizing and delivering PV trainings to other departments and other relevant stakeholders as delegated
Supporting planning submission and tracking of Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), Risk Management Plans and Company Core Safety Information (CCSI) activities as per local requirements and internal procedures
Supporting development, updates and tracking of additional Risk Minimization Measures (aRMM) and of PV agreements, as per internal procedures
Coordination of Health Hazard Assessments
Representing drug safety and providing relevant inputs in local projects and activities
CAPA management
Contributing to PSMF compliance
