Florham ParkFull TimeHealthcare
Remotely
oncologypharmacovigilanceregulatory submissionspatient safetyndacross functional teamspsurdsur
Job Description
📋 Description
- 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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