Senior Manager, Patient Safety Scientist

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary Partners with the Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize safe use of BMS medicines by evaluating and mitigating risks. Independently performs core signal detection activities and elevates program or portfolio issues impacting key SMT programs, priorities, resources, and milestones. Leads safety data review meetings (SDRMs). Ensures pharmacovigilance regulatory compliance. Duties/Responsibilities Signal Detection/Management & Safety Surveillance • Performs core signal detection and assessment activities throughout the product life cycle (including review of safety-related literature and quantitative signal detection). Demonstrates solid capability in utilizing available tools and data sources to investigate safety concerns, contributing to safety assessments with increasing autonomy and analytical insight. • Leads SDRMs by reviewing and evaluating clinical data to support signal detection and escalate issues impacting key SMT activities, milestones, and documents to the SMT Chair. • Executes strategy for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration, authors comprehensive signal reports and proactively manages and tracks signals within the signal management system, ensuring timely notification and engagement of all relevant stakeholders. • Prepares/writes safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER). • Analyzes data and writes ad hoc responses to health authorities, including supporting local markets in responding to risk management-related queries from local HAs. Clinical Development Product Support • Contributes to the preparation/review of safety sections in clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight. • Represents Patient Safety and supports safety strategy preparation at internal and external meetings (pre-submission, Advisory Committees, Scientific Advice, data monitoring committee, publications, etc.). Submission Planning & Postmarketing Product Support • Executes the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Reviews and authors safety sections of marketing authorization applications (MAA), with oversight, including safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), clinical overview, briefing documents, and initial product labeling (USPI, CCDS, SmPC). Contributes to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the product's benefit/risk profile. • Analyzes data and authors documentation as needed to support safety labeling updates to ensure labeling adequately reflects...