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Senior Director, Safety MD
Bristol Myers Squibb. Provide medical safety leadership across clinical development and pharmacovigilance activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance and safety science, with a strong focus on signal detection, risk management, and regulatory compliance. Proven ability to lead cross-functional teams and mentor colleagues while ensuring adherence to global pharmacovigilance regulations.
Highest-signal resume keywords
Pharmacovigilance StrategySignal DetectionRisk ManagementRegulatory ComplianceLeadership Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety EvaluationBenefit-Risk AssessmentAggregate Safety ReportingICSR/SAE Case ReviewsRegulatory Filings
Soft Skills
Strong Communication SkillsMentoringCollaboration
Tools & Technologies
AI for Performance Improvement
Certifications & Qualifications
MD or Equivalent
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryGlobal Pharmacovigilance RegulationsFDAEMAICH
About the role
Key responsibilities & impact- Provide medical safety leadership across clinical development and pharmacovigilance activities
- Lead or co-lead global pharmacovigilance strategy, proactive safety surveillance, signal detection, risk management, and regulatory compliance
- Establish and maintain safety governance structures, SOPs, and continuous improvement processes
- Partner with safety, clinical development, regulatory, medical affairs, and cross-functional teams
- Direct safety evaluation and benefit-risk assessment for clinical development and post-marketing products
- Represent Safety Science in safety management teams, study meetings, health authority interactions, submissions, safety reports, audits, and inspections
- Drive safety content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to inquiries
- Perform daily ICSR/SAE case reviews and support safety management across clinical trial phases
- Serve as a PV representative for regulatory authorities, external experts, scientific bodies, and industry groups
- Mentor cross-functional colleagues, direct reports, and safety team members
- Leverage AI to improve program, portfolio, or functional performance
- Serve as backup Safety MD for the PV Head
Requirements
What you’ll need- MD or equivalent
- 10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry
- Knowledge/awareness of current global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH
- Expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting
- Experience interacting with global regulatory authorities and scientific advisory bodies
- Strong leadership and communication skills
- Ability to work effectively in a matrixed, cross-functional environment
- Commitment to patient safety and ethics in medical practice
- 25% travel
Benefits
Comp & perks- Discretionary incentive cash
- Stock opportunities
- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life, and disability insurance offerings
- Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires for eligible non-exempt, RayzeBio, and Puerto Rico employees
- 3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico 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
- Reasonable workplace accommodations/adjustments and ongoing support