Director, Medical Safety Assessment Physician

Roles & Responsibilities
• Lead safety activities and benefit–risk strategies for assigned compounds/programs
• Chair Product Safety Management Team (SMT) meetings
• Oversee and review aggregate safety reports (DSURs, PBRERs) and safety sections of clinical and regulatory documents (Protocols, CSRs, IBs, ICFs, CTAs, MAAs)
• Lead safety signal detection, evaluation, and documentation (Safety Topic Reviews/Signal Reports)
• Drive safety labeling strategy and provide regulatory labeling input
• Act as global safety lead for compounds in development and marketed products
• Provide safety input to clinical development plans, study protocols, SAPs, CSRs, and regulatory responses
• Develop and execute benefit–risk management strategies and risk management plans (RMPs)
• Support Health Authority (HA), Advisory Committee, Scientific Advice, and Data Monitoring Committee (DMC) meetings
• Provide post-marketing safety oversight and regulatory submission support
• Contribute to publication strategy and ensure safety input in scientific communications
• Lead process improvement initiatives within Pharmacovigilance (PV)
• Support regulatory inspections, crisis management, and cross-functional issue resolution
• Act as liaison between Patient Safety and internal functions (Legal, Regulatory, Manufacturing, Medical Affairs, etc.)
• Mentor team members and promote collaboration within a matrix environment

Qualification
• MD or equivalent medical degree (mandatory)
• Postgraduate qualification or experience in Internal Medicine, Immunology, Oncology, or related specialty preferred

Experience
• Minimum 3+ years of experience in Pharmacovigilance or relevant pharmaceutical/biomedical field
• Experience in clinical research, regulatory, or medical roles considered valuable

Skills
• Strong understanding of drug development lifecycle
• In-depth knowledge of pharmacovigilance and global regulatory safety requirements
• Ability to evaluate safety signals and minimize patient risk
• Proficiency in benefit–risk assessment and observational research methods
• Strong analytical reasoning and scientific evaluation skills
• Ability to manage multiple projects simultaneously
• Excellent written and verbal communication skills
• Leadership capability in a complex cross-functional matrix environment
• High attention to detail and strong ethical standards

About the Company
Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that transform patients’ lives. With strong expertise across oncology, immunology, cardiovascular, and cell therapy, BMS is committed to advancing science while fostering a collaborative and inclusive workplace culture.