Responsibilities:
- Lead safety activities and benefit-risk strategies for assigned BMS compounds/program; chair product Safety Management Team(s).
- Oversee/review aggregate safety documents (e.g., DSUR, PBRER) and safety sections of clinical trial documents and regulatory filings.
- Lead signal evaluation/management; develop signal evaluation strategy and document outcomes.
- Lead safety labeling activities; act as Safety Subject Matter Expert for regulatory product labeling.
- Drive medical safety in clinical development and postmarketing phases, including benefit-risk management, safety risk language, risk management strategy, and RMP elements.
- Prepare/review safety submissions and responses to Health Authority/IRB/EC queries; represent WWPS at HA and DMC meetings.
- Lead PV process improvement; support inspections, issue/crisis management, and team collaboration.
Qualifications:
- MD/equivalent required; postgraduate training/experience in internal medicine, immunology, oncology, or related specialty desirable.
- 3+ years in PV or relevant pharma/biomedical field strongly preferred.
Skills/Knowledge:
- Drug development process knowledge; PV expertise for patient risk minimization across the product life cycle.
- Strong scientific/analytical reasoning, attention to detail, ability to manage multiple projects, and excellent verbal/written communication.