Lead pharmacovigilance and safety surveillance for oncology products across lifecycle
Set strategy for safety documents and risk management plans, NDA/sNDA safety components
Collaborate with PK/toxicology, regulatory, clinical development and medical affairs teams
Interpret regulatory PV guidance and author PV documents
Lead periodic safety reports (DSURs, PSURs, PADERs) and safety monitoring activities
Mentor and coach team; contribute to publications and safety leadership growth

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