The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, writing and or reviewing aggregate reports (DSURS, PSURS, PBRERs. PADERS), reviewing risk management reports (RMPs) and mentoring junior PV Physicians. 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. […]
• To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. Review includes...