Director, Medical Safety Assessment Physician
Core
Lead safety activities, benefit-risk strategies, and signal evaluation for assigned pharmaceutical compounds throughout the drug lifecycle.
Role type
Director, Medical Safety Assessment Physician
Builds
Regulatory filings, safety aggregate reports, risk management plans, and product labeling.
Domain
Pharmaceutical / Pharmacovigilance
Required skills
Medical degree (MD), Pharmacovigilance expertise, Drug development lifecycle knowledge, Regulatory safety assessment, Signal evaluation, Risk management strategy, Scientific analytical reasoning, Cross-functional leadership
Preferred skills
Postgraduate qualification in internal medicine/immunology/oncology, Clinical research experience, Observational research experience, 3+ years in PV or biomedical field
Technologies
DSUR, PBRER, CTA, MAA, RMP, SAP, IB, CSR
Responsibilities
Chair product Safety Management Teams, lead safety labeling activities, support EU Qualified Person for Pharmacovigilance, lead process improvement projects, provide input to R&D publications, act as global safety lead for development and postmarketing compounds, prepare safety strategy for regulatory meetings.
Seniority
Director, strategic leadership & team management