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. BMS 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 The Associate Director, Patient Safety Scientist, is a 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. The Associate Director independently performs core signal detection activities and elevates program or portfolio issues impacting key SMT programs, priorities, resources, and milestones. He/She leads safety data review meetings (SDRMs) and ensures pharmacovigilance regulatory compliance. Duties & 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. 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. Education & Experience 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 6 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor others #LI-Hybrid Compensation Overview Madison - Giralda - NJ - US: $150,300 - $182,125 Princeton - NJ - US: $150,300 - $182,125 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. 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, direct your inquiries to View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility 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. 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 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1604395 : Associate Director, Patient Safety Scientist #J-18808-Ljbffr Bristol-Myers Squibb