Associate Director, 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. 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 (e.g., 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 (e.g., 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 (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. 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. Cross Functional Activities Leads or identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents. Builds cross-functional partnerships with SMT/ACT stakeholders, exercising matrix leadership to drive alignment, accountability, and timely decision-making across functions. Possesses deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; shares with cross-functional teams as needed. Degree Requirements Scientific degree (e.g., 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. Travel Required (nature and frequency) N/A 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. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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 . Visit to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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