Pharmacovigilance Lead Aggregate Reporting

Job description

Pharmacovigilance Lead Aggregate Reporting Position Summary: The PV Aggregate Reporting Lead is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggregate safety reports across assigned client portfolios. The role encompasses the full lifecycle of periodic and aggregate reporting — including PSURs/PBRERs, DSURs, PADERs, ADCOs, and Line Listings, in compliance with EMA GVP Module VII, ICH E2C(R2), ICH E2F, and FDA requirements. The role acts as the subject matter expert for aggregate reporting and collaborates with signal management, case processing, medical review, and client teams to deliver submission-ready documents within regulatory deadlines. Essential Functions: Coordinate data collection from all relevant teams to ensure report completeness and accuracy. Education: Advanced degree in life sciences - pharmacy (PharmD), or Medicine(MD) preferred. A postgraduate qualification in regulatory affairs, Pharmacoepidemiology, or drug safety is an advantage. Experience: Minimum 4 years of PV experience, with at least 2 years focused on aggregate/periodic safety report writing at a PV vendor, CRO, or pharmaceutical company. End-to-...