PrimeVigilance
2 open remote positions
✨ Benefits Overview (2 of 2 jobs list additional benefits)
Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. This includes coding, assessment of seriousness, expectedness, and company causality, as well as writing of company comment, follow-up questions and analysis of similar events.
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.