Associate Director, Patient Safety Scientist

Bristol Myers Squibb

. Partner with and advise the Medical Safety Assessment Physician/Safety Management Team Chair on safe use of medicines and safety evidence .

Posted 10/9/2026full-timePrinceton • New Jersey • United StatesSenior💰 $150,300 - $182,125 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance and safety assessment, with a strong ability to analyze and synthesize complex medical data while ensuring compliance with regulatory requirements. Proficient in leading safety evaluations, authoring regulatory documents, and collaborating with cross-functional teams to enhance patient safety.

Highest-signal resume keywords

Pharmacovigilance ExperienceSignal Detection and AssessmentRegulatory ComplianceData Analysis and InterpretationMentoring and Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Signal DetectionSafety Data ReviewRisk Management DocumentationClinical Trial Protocol PreparationData AnalysisQuantitative Signal DetectionSafety Literature ReviewPharmacovigilance ActivitiesMedical Concept UnderstandingStatistical Methods

Soft Skills

Strong CommunicationCollaborationOrganizational SkillsPrioritizationAbility to Work Independently

Tools & Technologies

AI ToolsAutomationDigital PlatformsHealth Authority DatabasesClaims Databases

Certifications & Qualifications

Scientific Degree (BS, MS, RN, PharmD, PhD, MD)

Industry Keywords

Pharmaceutical IndustryDrug DevelopmentPatient SafetyRegulatory FilingsRisk Minimization Measures

About the role

Key responsibilities & impact

Partner with and advise the Medical Safety Assessment Physician/Safety Management Team Chair on safe use of medicines and safety evidence
Perform signal detection and assessment throughout the product life cycle, including safety literature review and quantitative signal detection
Lead safety data review meetings and escalate issues affecting programs, milestones, documents, priorities, and resources
Drive signal evaluation strategy and execution using case series, literature reviews, health authority databases, and claims databases
Author signal reports, aggregate safety documents, regulatory responses, and risk management documentation
Prepare and review safety sections for clinical trial protocols, CSRs, investigator brochures, informed consent forms, and contraception language
Represent Patient Safety at internal and external meetings, including advisory committees, scientific advice, data monitoring committees, and publications
Support regulatory filings, safety strategies, key safety messages, risk management approaches, marketing authorization applications, labeling, and safety updates
Support EU QPPV or regional/local QP activities for assigned products
Create and update EDSR, structured benefit-risk assessments, Company Core Risk Management, and global/EU Risk Management Plans
Lead and oversee additional risk minimization measures and additional pharmacovigilance activities globally and locally
Guide local markets and vendors on complex and non-complex risk minimization measures
Leverage automation, AI, and innovation tools to improve processes and decision-making
Collaborate with Therapeutic Area staff and contribute to continuous improvement
Support regulatory inspections and audits and assess process alignment with regulatory requirements

Requirements

What you’ll need

Scientific degree (eg, BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience
Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience
Ability to mentor others
Deep understanding of medical concepts and safety activities
Experience synthesizing clinical, nonclinical, postmarketing, and literature data
Strong communication, collaboration, organizational, and prioritization skills
Ability to work independently and as a team player in dynamic, fast-paced environments
Scientific training and ability to interpret complex medical data across disciplines
Understanding of data analysis, interpretation, presentation, and foundational statistical methods
Growing ability to use AI, automation, and digital platforms
Ability to operate in compliance with regulatory expectations, guidelines, and mandates

Benefits

Comp & perks

Additional discretionary incentive cash and stock opportunities
Wellbeing support
Retirement and financial protection benefits
Medical, dental, vision, life and disability insurance
Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees
11 paid company holidays each year
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
Paid sick leave, depending on eligibility
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
Reasonable workplace accommodations/adjustments and ongoing support
Opportunities for growth and a supportive, inclusive environment