Oversee the end-to-end ICSR management framework (intake, processing, in-stream quality review, regulatory submission oversight, and retrospective quality review), ensuring timeliness, accuracy, and compliance with global regulations (21 CFR, EU GVP, ICH E2 series). Lead oversight of outsourced PV activities and the CROs and vendors that support them, establishing governance, KPIs/KQIs, scorecards, and performance reviews, and driving corrective actions when performance falls short.