Director, Medical Safety Assessment Physician

Bristol Myers Squibb • Princeton, NJ

11d

About The Position

Lead safety activities and benefit-risk strategies for assigned BMS compounds and programs, chair product Safety Management Teams, and oversee safety assessments across clinical development and postmarketing. The role involves evaluating and managing safety signals from all data sources, developing signal evaluation strategies, leading safety labeling activities, and providing safety expertise for regulatory product labeling. It also supports regional and local pharmacovigilance qualified persons, publication planning, regulatory interactions, and data monitoring committee activities.

For products in development, serve as the global safety lead, guide benefit-risk management, contribute safety input to development plans and clinical documents, and support global submission preparation. For marketed products, lead postmarketing safety activities, aggregate safety reporting, risk management strategies, signal evaluation, safety labeling, and guidance for postmarketing studies. The role also contributes to pharmacovigilance process improvement, inspection readiness, issue and crisis management, training, cross-functional product safety communications, and collaboration across BMS functions.

Ensure work is efficient and meets standards for quality, accuracy, timeliness, global regulatory compliance, and cost effectiveness. The role requires occasional travel within the United States and overseas.

Requirements

• MD or equivalent required.
• Three or more years in pharmacovigilance or a relevant pharmaceutical or biomedical field (such as Medical, Clinical, or Regulatory) is strongly preferred.
• Understanding of the drug development process.
• Knowledge of pharmacovigilance and ability to apply it to safety concern evaluation and patient risk minimization throughout a drug product's lifecycle.
• Ability to use available tools to investigate safety concerns, including knowledge of observational research.
• Understanding of regulatory requirements for safety assessment and action.
• Strong scientific analytical reasoning skills.
• Ability to manage multiple projects in parallel.
• Excellent attention to detail.
• Behavioral competencies to work and lead in a complex matrix environment.
• Excellent verbal and written communication skills.
• Occasional travel within the US (for example, once every 2–3 months) and overseas (for example, once a year).

Nice To Haves

• Postgraduate qualification or experience in internal medicine, immunology, oncology, or a related specialty.
• Relevant experience or accomplishments in clinical research, observational research, or clinical practice.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned compounds and chair product Safety Management Teams.
• Oversee, prepare, and/or review aggregate safety review documents, clinical trial document safety sections, and regulatory filings.
• Lead the evaluation and management of safety signals from any data source; develop signal evaluation strategies and document outcomes.
• Lead safety labeling activities, provide safety subject-matter expertise for regulatory labeling, and support cross-functional and regional labeling work.
• Support the EU Qualified Person for Pharmacovigilance and other regional or local pharmacovigilance qualified persons on assigned product issues.
• Provide safety input to R&D publication strategy and ensure safety input to publications and presentations.
• Serve as the global safety lead for assigned compounds in development and support global submission document production.
• Develop and execute benefit-risk management strategies and provide safety input to clinical development plans, protocols, amendments, investigator brochures, statistical analysis plans, informed consent forms, clinical study reports, and responses to health authority or ethics committee queries.
• Lead development of safety risk language, risk management strategy, pre-filing safety activities, integrated safety reviews, and safety-focused publications.
• Perform medical safety review of development safety update reports, annual reports, and other periodic safety submissions.
• Support safety strategy preparation for pre-submission, advisory committee, scientific advice, and data monitoring committee meetings.
• Lead safety activities for assigned marketed compounds, including global postmarketing safety activities and submissions.
• Provide medical safety and benefit-risk input for aggregate reports, product renewal submissions, postmarketing study documents and reports, and responses to health authority queries.
• Lead medical safety oversight and execution of risk management strategies and risk management plan elements.
• Prepare and review safety signal reports and ad hoc regulatory responses; guide postmarketing safety studies conducted by other groups.
• Ensure safety labeling reflects emerging postmarketing safety information.
• Lead process improvement projects and help develop and maintain pharmacovigilance processes and procedures within BMS R&D and WWPS.
• Support regulatory inspection preparation by evaluating processes and their alignment with regulatory expectations, guidelines, and mandates.
• Assist with issue and crisis management; liaise with therapeutic area staff and maintain a collaborative patient safety team.
• Support hiring and orientation.
• Contribute to strategic plans for safety differentiation of BMS products and prepare and provide employee training on product safety profiles and issues.
• Act as WWPS liaison for assigned products with BMS functions, including Legal, Business Development, Operations, and Marketing.
• Support manufacturing quality, co-author integrated health hazard assessments, and develop safety data communications and interpretation for internal and external audiences.
• Promote teamwork and collegiality, and mentor and support colleagues as a positive change agent.

Benefits

• Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid company holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
• Additional discretionary incentive cash and stock opportunities may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree