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The Patient Safety group is responsible for ensuring the safety of our medicines by providing pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and ensuring compliance with global regulatory requirements.
Signal Detection/Management & Safety Surveillance
Performs core signal detection and assessment activities throughout the product life cycle (including review of safety-related literature and quantitative signal detection). Demonstrates solid capability in utilizing available tools and data sources to investigate safety concerns, contributing to safety assessments with increasing autonomy and analytical insight.
Leads SDRMs by reviewing and evaluating clinical data to support signal detection and escalate issues impacting key SMT activities, milestones, and documents to the SMT Chair.
Executes strategy for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration, authors comprehensive signal reports, and proactively manages and tracks signals within the signal management system, ensuring timely notification and engagement of all relevant stakeholders.
Prepares/writes safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
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Analyzes data and writes ad hoc responses to health authorities, including supporting local markets in responding to risk management-related queries from local HAs.
Clinical Development Product Support
Contributes to the preparation/review of safety sections in 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, with oversight.
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), with oversight, 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). Contributes to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the product's benefit/risk profile.
Analyzes data and authors documentation as needed to support safety labeling updates to ensure labeling adequately reflects the 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 the 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).
Develops and maintains global and EU local Risk Management Plans (RMPs) and understands in-licensing or pharmacovigilance agreements that may impact risk management activities.
Develops and maintains core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Coordinates with 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. Uses 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.
Participates in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct.
Cross Functional Activities
Collaborates on and identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents.
Builds cross-functional partnerships with SMT and ACT membership and stakeholders.
Maintains solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; shares with cross-functional teams as needed.
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 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience.
Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
Working understanding of team priorities and milestones. Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality.
Adaptable / flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
Applies attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
Understands aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics, with basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards.
Travel Required (nature and frequency)
N/A
If you come across a role that intrigues you but doesn’t 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.
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, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
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Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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