Pharmacovigilance Specialist (m/w/d)

- Active participation in the preparation and finalization of Safety Update Reports (SUR) - Contributing to the creation and completion of reports that provide updates on the safety of a drug or medical device - Calculating sales/incidence and checking the quality of adverse event data - Support with the preparation of PV documents (e.g., Requests for PV Information (RPI), Pharmacovigilance Safety Master File (PSMF), PV statements, Product Benefit Risk Evaluation Reports) and archiving all PV related communications - Creation of workflows used to track PV related activities by designing and implementing processes that help track and manage various activities related to pharmacovigilance, including follow-up updates - Support with annual sales submission to competent authorities as required - Miscellaneous - pro-active collaboration with other PV Specialist colleagues on various tasks (e.g., compliance monitoring - KPls/Metrics) and handling other tasks as assigned by supervisor or PV management