Senior Manager, Patient Safety Scientist Full-time NEW

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.

Job Description

The Patient Safety group is responsible for ensuring the safety of our medicines by providing pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and ensuring compliance with global regulatory requirements.

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 on 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 the emerging postmarketing safety profile.
• Supports the EU QPPV or other regional/local QP for safety issues on assigned products.

Risk Management Planning & Execution

• Responsible for the creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/ governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS).
• Develops and maintains global and EU local Risk Management Plans (RMPs) and understands in-licensing or pharmacovigilance agreements that may impact risk management activities.
• Develops and maintains core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Coordinates with local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials).

Department Activities

• Leverages automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements. Uses multiple data sources and AI generated outputs to support decisions.
• Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates.
• Participates in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct.

Cross Functional Activities

• Collaborates on and identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents.
• Builds cross-functional partnerships with SMT and ACT membership and stakeholders.
• Maintains solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; shares with cross-functional teams as needed.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ “, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.