Senior Manager, Pharmacovigilance Scientist

Bristol Myers Squibb

. Partner with the Medical Safety Assessment Physician/Safety Management Team Chair to characterize safe use of BMS medicines .

Posted 10/9/2026full-timePrinceton • New Jersey • United StatesSenior💰 $146,050 - $176,975 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and risk management, with a strong ability to analyze complex medical data and prepare regulatory documents. Proficient in collaborating with cross-functional teams and managing safety-related queries from health authorities.

Highest-signal resume keywords

Pharmacovigilance ExperienceSignal Detection and AssessmentRegulatory Document PreparationData Analysis and InterpretationCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Signal Evaluation StrategiesQuantitative Signal DetectionRisk Management PlansAggregate Safety DocumentsMedical Concepts UnderstandingData AnalysisBasic StatisticsPharmaceutical Industry KnowledgeSafety Activities FamiliarityHealth Authority Requirements

Soft Skills

Attention to DetailOrganizational SkillsAdaptabilityCommunication SkillsAnalytical Skills

Tools & Technologies

Automation ToolsAI-Generated OutputsDigital PlatformsHealth Authority DatabasesClaims Databases

Industry Keywords

Drug DevelopmentPostmarketing SafetyPatient SafetyRisk Minimization MeasuresClinical Trial Documents

About the role

Key responsibilities & impact

Partner with the Medical Safety Assessment Physician/Safety Management Team Chair to characterize safe use of BMS medicines
Evaluate and mitigate product risks
Perform core signal detection and assessment throughout the product life cycle
Review safety-related literature and conduct quantitative signal detection
Lead safety data review meetings and escalate issues affecting SMT activities, milestones, and documents
Execute signal evaluation strategies using case series, literature reviews, health authority databases, and claims databases
Author signal reports and manage signals in the signal management system
Prepare safety and risk management sections of aggregate safety documents, including DSURs, PBRERs, and PADERs
Analyze data and write responses to health authorities
Support local markets with risk-management-related health authority queries
Prepare and review safety sections of clinical trial documents, including protocols, CSRs, investigator brochures, informed consent forms, and contraception language
Represent Patient Safety at internal and external meetings
Support regulatory filing safety strategies and author safety sections of marketing authorization applications
Support safety labeling updates and regulatory safety requests
Support EU QPPV or regional/local QP activities
Create and update EDSRs, Structured Benefit Risk assessments, Company Core Risk Management strategies, and Risk Management Plans
Develop and maintain global and EU local RMPs, additional Risk Minimization Measures, and additional Pharmacovigilance Activities
Coordinate with local markets and vendors on complex and non-complex risk-minimization measures
Use automation, AI-generated outputs, and multiple data sources to support decisions and improve workflows
Support regulatory inspections and audits
Contribute to Patient Safety Science process improvements and procedural documents
Build cross-functional partnerships with SMT, ACT members, and stakeholders
Maintain and share knowledge of product goals, drug development milestones, partnership agreements, health authority commitments, and global regulations

Requirements

What you’ll need

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, or drug development experience
Working understanding of medical concepts
Familiarity with safety activities in drug development and postmarketing
Familiarity with global safety health authority requirements
Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills
Adaptability and flexibility to adjust to multiple demands and shifting priorities
Strong attention to detail and scientific, analytical, and conceptual skills
Scientific training to understand complex medical-scientific data across clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents
Understanding of data analysis, interpretation, and presentation, including basic statistics
Basic ability to apply emerging technologies, including AI, automation tools, and digital platforms

Benefits

Comp & perks

Comprehensive wellbeing support, retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) for U.S.-based exempt employees
11 paid company holidays annually
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible employees
Paid sick leave
Up to two paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
Annual Global Shutdown between Christmas Day and New Year's Day
Additional discretionary incentive cash and stock opportunities
Workplace accommodations/adjustments and ongoing support for people with disabilities