Director, Pharmacovigilance Scientist

Overview

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.

Bristol Myers Squibb 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:

The 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. 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.

Signal Detection/Management & Safety Surveillance
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• 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.

Clinical Development Product Support
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• 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
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• 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…