Director, Medical Safety Assessment

Bristol Myers Squibb

. Lead safety activities and benefit-risk strategies for assigned BMS compounds and programs .

Posted 10/30/2026full-timePrinceton • New Jersey • United StatesLead💰 $255,860 - $310,040 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance, safety signal evaluation, and regulatory compliance, with a strong focus on risk management and safety strategy development. Proven ability to lead cross-functional teams and communicate effectively across various stakeholders in the pharmaceutical industry.

Highest-signal resume keywords

PharmacovigilanceSafety Signal EvaluationRegulatory ComplianceRisk Management StrategiesMedical Safety Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Review DocumentsClinical Trial Safety SectionsAggregate Safety ReportsSafety Labeling ActivitiesSignal ReportsRisk-Management StrategiesMedical Safety ReviewsData Monitoring Committee MeetingsIntegrated Safety-Data ReviewsObservational Research Science

Soft Skills

Excellent Attention to DetailExcellent Verbal CommunicationExcellent Written CommunicationBehavioral Competencies in Matrix EnvironmentMentoring and Support

Certifications & Qualifications

MD/Equivalent

Industry Keywords

Drug Development ProcessPharmaceutical IndustryBiomedical FieldPatient SafetyHealth-Authority Responses

About the role

Key responsibilities & impact

Lead safety activities and benefit-risk strategies for assigned BMS compounds and programs
Chair product Safety Management Teams
Oversee, prepare, and review aggregate safety review documents, clinical trial safety sections, and regulatory filings
Lead evaluation and management of safety signals from any data source
Develop signal-evaluation strategies and document outcomes through Safety Topic Reviews, Signal Reports, or other communications
Lead safety labeling activities and provide subject-matter expertise for regulatory product labeling
Provide regional safety-labeling support and participate in cross-functional labeling meetings
Act as global safety lead for compounds in development and support global submission document production
Provide safety input to clinical development plans, protocols, amendments, investigator brochures, statistical analysis plans, informed consent forms, clinical study reports, and regulatory or ethics-committee responses
Lead development of safety-risk language, risk-management strategies, pre-filing safety activities, integrated safety-data reviews, and safety-focused publications
Perform medical safety reviews of DSURs, annual reports, and periodic safety submissions
Support safety strategy preparation for regulatory, advisory committee, scientific advice, and Data Monitoring Committee meetings
Act as safety lead for marketed compounds and support global postmarketing safety activities and submissions
Provide medical safety and benefit-risk input for aggregate reports, product renewals, postmarketing studies, and health-authority responses
Lead medical safety oversight and execution of risk-management strategies and RMP elements
Provide postmarketing safety-study guidance to epidemiology and medical affairs groups
Lead process-improvement projects and help maintain pharmacovigilance processes and procedures
Support preparation for regulatory inspections and assess alignment with regulatory expectations
Assist with issue and crisis management
Liaise with Therapeutic Area staff and maintain a collaborative patient-safety team
Support hiring and orientation
Prepare and provide product-safety training to BMS employees
Act as WWPS liaison with Legal, Business Development, Operations, Marketing, and other BMS functions
Support manufacturing quality and co-author integrated health-hazard assessments
Develop global communications of safety data and interpretation
Mentor and support colleagues as a positive change agent

Requirements

What you’ll need

MD/equivalent required
Postgraduate qualification or experience in internal medicine, immunology, oncology, or a related specialty desirable
3+ years in pharmacovigilance (PV) or a relevant pharmaceutical or biomedical field strongly preferred
Understanding of the drug development process
Knowledge of pharmacovigilance and ability to evaluate safety concerns and minimize patient risk throughout a drug product's life cycle
Ability to leverage available tools to investigate safety concerns, including observational research science
Understanding of regulatory requirements for safety assessment and action
Strong scientific analytical reasoning skills
Ability to work on multiple projects in parallel
Excellent attention to detail
Behavioral competencies to work and lead within a complex matrix environment
Excellent verbal and written communication skills
Occasional travel within the US, approximately once every 2–3 months, and overseas, approximately once a year
Must meet applicable work authorization and employment eligibility requirements

Benefits

Comp & perks

Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance
Flexible Time Off (FTO) without a set accrual limit for U.S.-based exempt employees, subject to manager approval
11 paid company holidays each year
160 hours of paid vacation annually for eligible new hires, subject to manager approval
3 optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
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
Wellbeing support
Additional discretionary incentive cash and stock opportunities
Reasonable workplace accommodations/adjustments and ongoing support
Flexible work models, including site-essential, site-by-design, field-based and remote-by-design