Director, Patient Safety Scientist

Position Summary

The Director, Patient Safety Scientist, is a key partner and strategic advisor to the Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence. The role evaluates and mitigates risks, performs core signal detection activities, leads safety data review meetings, and ensures pharmacovigilance regulatory compliance.

Signal Detection/Management & Safety Surveillance

• Develop and co‑develop the global safety strategy in partnership with the SMT Chair, overseeing signal detection and assessment across the product lifecycle for multiple complex compounds.
• Lead execution for signal evaluation (e.g., case‑series, literature review, health authority/claims databases), promote cross‑functional collaboration, develop clear preliminary conclusions, and ensure timely tracking, stakeholder engagement, and documentation within the signal management system.
• Create medical writing for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
• Develop strategy, analyze data, and write ad‑hoc responses to health authorities, support local markets, and mentor less experienced scientists.

Clinical Development Product Support

• Lead the preparation, review, and strategic input for safety sections in key clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB), informed consent forms (ICF), and contraception language.
• Represent Patient Safety and support safety strategy preparation at internal and external meetings (pre‑submission, Advisory Committees, Scientific Advice, data monitoring committee, publications, etc.).

Submission Planning & Postmarketing Product Support

• Co‑develop safety strategy and input for regulatory filings, including the formulation of safety strategy, key safety messages, and risk management approaches.
• Author safety sections on marketing authorization applications (MAA), safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), and initial product labeling.
• Lead cross‑functional responses to ad‑hoc regulatory safety requests and support safety labeling updates.
• Support the EU QPPV or other regional/local QP for safety issues on assigned products.

Risk Management Planning & Execution

• Create strategy for EDSR creation and update, support Structured Benefit Risk, and define strategy for Company Core Risk Management.
• Lead development and maintenance of global and EU Risk Management Plans (RMPs) and oversee revisions to core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs).
• Provide guidance to local markets and vendors for complex aRMMs, such as Pregnancy Prevention Programs and Controlled Distribution Programs.

Department Activities

• Oversee a global team of safety scientists and risk management experts within the assigned therapeutic area.
• Leverage automation, innovation tools, and AI to support decision‑making and drive digital change initiatives.
• Support preparation for regulatory inspections and audits, assessing alignment with regulatory expectations.
• Foster a high‑performing and collaborative safety team through strategic partnership and role modeling.

Cross‑Functional Activities

• Lead or identify opportunities for process improvements and cross‑functional initiatives, including procedural document maintenance.
• Build cross‑functional partnerships with SMT/ACT stakeholders, exercising matrix leadership for alignment and timely decision‑making.
• Share deep knowledge of product goals, strategy, milestones, partnership agreements, HA commitments, and regulatory trends with cross‑functional teams.

• Demonstrated ability to develop and execute safety strategy across complex, cross‑functional initiatives in drug development, pharmacovigilance, and global regulatory safety.
• Deep scientific and medical expertise with the ability to synthesize complex data to inform strategic decisions.
• Strong decision‑making skills grounded in scientific rigor and sound judgment.
• Effective…