Associate Director, Patient Safety Scientist

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.