Director, Medical Safety Assessment Physician

Role & Responsibilities
• Lead safety activities and benefit-risk strategies for assigned BMS compounds/programs and chair Safety Management Teams (SMTs)
• Oversee, prepare, and review aggregate safety reports including DSUR, PBRER, and safety sections of clinical and regulatory documents (CSR, IB, ICF, CTA, MAA)
• Lead evaluation and management of safety signals from all data sources and document outcomes through Safety Topic Reviews/Signal Reports
• Drive safety labeling activities and act as Safety Subject Matter Expert for regulatory product labeling
• Act as global safety lead for compounds in development and marketed products
• Provide safety input to clinical development plans, protocols, SAP, CSRs, and regulatory responses
• Lead medical safety risk management strategies including RMP elements and postmarketing commitments
• Represent Patient Safety (PS) at Health Authority (HA), Advisory Committee, and Data Monitoring Committee (DMC) meetings
• Support EU QPPV and other regional PV responsible persons
• Lead process improvement initiatives and contribute to development of state-of-the-art pharmacovigilance processes
• Prepare safety strategy for submissions and pre-filing activities including integrated safety summaries
• Provide cross-functional liaison with Legal, Regulatory, Clinical, Manufacturing, Marketing, and Medical Affairs teams
• Mentor colleagues and promote teamwork within a complex matrix environment

Qualification
• MD or equivalent medical degree required
• Postgraduate qualification or experience in Internal Medicine, Immunology, Oncology, or related specialty desirable

Experience
• Minimum 3+ years of experience in Pharmacovigilance or relevant pharmaceutical/biomedical field (Medical, Clinical, Regulatory) preferred
• Experience in clinical research, observational research, or clinical practice considered

Skills
• Strong understanding of drug development lifecycle and pharmacovigilance processes
• Expertise in safety signal evaluation and benefit-risk assessment
• Knowledge of global regulatory requirements for safety reporting
• Strong analytical and scientific reasoning skills
• Ability to manage multiple projects simultaneously
• Excellent attention to detail
• Strong verbal and written communication skills
• Leadership capability in cross-functional and matrix environments

About the Company
Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients’ lives through science. The company focuses on innovative research and development across oncology, immunology, cardiovascular, and other therapeutic areas. With a strong commitment to scientific excellence, regulatory compliance, and patient safety, BMS offers a collaborative and growth-oriented environment supporting impactful, life-changing work worldwide.