Role Overview
The Drug Safety & Pharmacovigilance (GDS&PV) Physician is a senior medical expert responsible for contributing to the global safety strategy and safety profile of assigned products throughout their lifecycle.
As a Director-level individual contributor, you will engage cross-functionally and with external stakeholders, including regulatory authorities, to manage safety assessments, review adverse events and scientific literature, prepare safety reports, and communicate risk profile changes.
You will lead safety activities, oversee risk mitigation, provide guidance on safety documentation, and manage safety forums. Additionally, you will mentor junior colleagues, lead safety training, and act as a safety ambassador across the organization.
**Qualifications & Skills:**
– Medical degree (MD) with 12+ years in drug safety/pharmacovigilance, preferably in oncology.
– Experience with regulatory submissions, audits, and working with agencies such as FDA.
– Knowledge of global PV regulations, coding dictionaries, and safety database systems.
– Proven leadership in guiding and mentoring teams.
**Key Duties:**
– Manage safety activities, benefit-risk evaluations, and risk management.
– Collaborate on safety assessments and surveillance.
– Prepare regulatory safety documentation.
– Lead safety forums and internal/external communications.
– Train and mentor team members on PV principles and regulations.