Bristol Myers Squibb · 1 day ago
Director, Pharmacovigilance Scientist
Princeton - NJ - US
Full-time
Onsite
Director/Executive
$218K/yr - $264K/yr
8+ years expBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. The Director, Pharmacovigilance Scientist will be responsible for developing safety strategies, leading signal detection activities, and ensuring regulatory compliance in pharmacovigilance. This role involves collaboration with cross-functional teams and oversight of safety data management across multiple products.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Develops or co-develops the global safety strategy in partnership with the SMT Chair, overseeing signal detection and assessment across the product lifecycle for multiple complex compounds. Utilizes advanced tools and diverse data sources to investigate safety concerns, enabling proactive risk management and informed decision-making
Leads execution for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration with authors for comprehensive signal reports, develops clear preliminary conclusions, and ensures timely tracking, stakeholder engagement, and documentation within the signal management system
Develops strategy and provides strong medical writing for safety and risk management sections of aggregate safety documents (eg, DSUR, PBRER, PADER)
Develops 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
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.)
In partnership with the SMT Chair, co-develops safety strategy and input for regulatory filings, including the formulation of safety strategy, key safety messages, and risk management approaches. Provides expert oversight and authorship of safety sections on marketing authorization applications (MAA), 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). Leads cross-functional 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 expert analysis and strategic input, analyzes data, and authors documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile
Creates strategy 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)
Oversees a global team of safety scientists and risk management experts within the assigned therapeutic area
Leverages automation and innovation tools into day-to-day work. Drives digital change initiatives, including management of stakeholder expectations and overcoming resistance. Uses multiple data sources and AI generated outputs to support decisions
Supports preparation for regulatory inspections and audits as a subject matter expert through proactive evaluation of current processes; assesses alignment with regulatory expectations, guidelines, and mandates
Fosters a high-performing and collaborative safety team by actively engaging with all TA staff, serving as a strategic partner and role model in cross-functional interactions, and promoting a culture of excellence, accountability, and continuous improvement
Leads or identifies opportunities for process improvements and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents
Builds cross-functional partnerships with SMT/ACT stakeholders, exercising strong matrix leadership to drive alignment, accountability, and timely decision-making across functions
Qualification
Required
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 8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; demonstrated ability to mentor and coach others
Demonstrated ability to develop and execute safety strategy across complex, cross-functional initiatives in drug development, pharmacovigilance, and global regulatory safety
Deep scientific and medical expertise with the ability to synthesize complex data (clinical, nonclinical, postmarketing, literature) to inform strategic decisions and influence stakeholders
Strong decision-making skills grounded in scientific rigor, sound judgment, and experience
Effective matrix leader with strong organizational, facilitation, and communication skills to drive alignment and engagement across internal and external networks, and senior leaders
Highly adaptable and resilient in dynamic environments; consistently demonstrates initiative and professionalism
Ability to incorporate emerging technologies (including AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort, while maintaining scientific rigor and compliance with safety standards
Benefits
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.33BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.75B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-02-05
2026-02-05
Company data provided by crunchbase