PrimeVigilance

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.

The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, aggregate reports (DSURS, PSURS, PBRERs. PADERS), and risk management reports (RMPs). The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.

For our clients, review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Contribute to the preparation of PV procedures and support the Project Manager, as well as the QPPV, on a day to day basis as needed.