Associate Director, Patient Safety Scientist

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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 (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 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 products benefit-risk profile.
• Provides input into strategy analyzes data and authors documentation as needed to support safety labeling updates to adequately reflect emerging post marketing 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 (e.g. 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. 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.

Requirements

• Scientific degree (e.g. BS MS RN PharmD PhD MD) or other degree with the equivalent combination of relevant education and professional experience
• Experience Requirements 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 effective 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.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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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

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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

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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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