Pharmacovigilance Aggregate Reporting Lead

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

• Lead and supervise the planning, writing, compilation, quality review and submission of PSURs/PBRERs, DSURs, PADERs, ADCOs, and Line Listings for assigned client products.
• Develop and maintain aggregate reporti...

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