Bristol-Myers Squibb→
Associate Director, Patient Safety… at Bristol-Myers… · Madison
Job Description
Associate Director, Patient Safety Scientist
Location: Madison - Giralda Farms
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a 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
Key partner and strategic advisor to Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making for assets in development and marketed products 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.
Position Responsibilities
Signal Detection/Management & Safety Surveillance
- Drives core signal detection and assessment activities, in partnership with the SMT Chair, throughout product life cycle (including review of safety-related literature and quantitative signal detection). Demonstrates strong capability in using a wide range of tools/data sources to assess safety concerns, enabling informed decision-making and proactive risk management.
- Leads SDRMs by reviewing and evaluating clinical data to support signal detection. Appropriately escalates issues impacting key SMT activities, milestones, and documents to the SMT Chair, demonstrating sound judgment and strategic awareness.
- Drives the strategy and execution for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration, authors comprehensive signal reports with clear preliminary conclusions, and ensures timely tracking, stakeholder engagement, and documentation within the signal management system.
- Executes strategy and provides strong medical writing for safety and risk management sections of aggregate safety documents (eg, DSUR, PBRER, PADER).
- Executes strategy, analyzes data, and writes ad hoc responses to health authorities (including supporting local markets in responding to risk management-related queries from local HAs), and mentors less experienced scientists in this area.
Clinical Development Product Support
- Leads the preparation, review, and strategic input for safety sections in key 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.
- 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), including safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), clinical overview, briefing book, and initial product labeling (USPI, CCDS, SmPC). Authors responses to ad hoc regulatory safety requests (eg, 120-day safety updates), proactively sourcing and interpreting safety data to evaluate the impact of emerging safety issues on the product’s benefit-risk profile.
- Provides input into strategy, analyzes data, and authors documentation as needed to support safety labeling updates to adequately reflect 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 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).
- Provides strategic leadership and is accountable for the development and maintenance of global and EU Risk Management Plans (RMPs), including understanding of in-licensing arrangements or pharmacovigilance agreements that may impact risk management activities.
- Leads and oversees the creation and revisions to core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Provides guidance to 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. Use multiple data sources and AI generated outputs to support decisions.
- Cultivates effective collaboration by engaging regularly with all TA staff, serving as a role model in cross-functional interactions, and contributing to a culture of excellence, accountability, and continuous improvement.
- Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates.
Position Requirments
- Scientific degree (eg, BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience
- Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor others
- Co-develops and executes safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders, leveraging deep understanding of medical concepts and safety activities
- .Effectively manages team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalating risks to timelines or deliverables. Consistently demonstrates initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments.
- Makes sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; applies exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights.
- Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methods, with growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and compliance.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t 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 Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How 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 https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1607213 : Associate Director, Patient Safety Scientist