Senior Manager, Pharmacovigilance Scientist

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

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) and ensures pharmacovigilance regulatory compliance.

Position 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 escalates 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 (eg 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 (eg 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the products 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 (eg Pregnancy Prevention Programs Controlled Distribution Programs) and non-complex aRMMs (eg 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.

Position Requirements

• Scientific degree (eg BS MS RN PharmD PhD MD) or other degree with the equivalent combination of relevant education and professional experience
• Minimum of 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience
• Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
• Working understanding of team priorities and milestones. Ability to manage timelines and quality of work through communication cross-functional collaboration and organizational skills appropriately communicating items that could impact timelines or quality.
• Adaptable / flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Applies attention to detail along with strong scientific analytical and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (eg clinical and nonclinical data postmarketing reports scientific literature and regulatory documents).
• Understands aspects and methods for data analysis interpretation and presentation including an understanding of basic statistics with basic ability to begin applying emerging technologies (AI automation tools and digital platforms) to streamline workflows enhance data analysis and reduce manual effort to ensure compliance with safety standards.

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

Compensation Overview:

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

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BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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Required Experience:

Senior Manager