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Senior Director, Medical Safety – Pharmacovigilance
Cytokinetics. Provide strategic and medical leadership for global safety surveillance and risk management activities across investigational and marketed products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance and drug safety leadership, ensuring compliance with global regulations while effectively managing safety surveillance and risk management activities. Proven ability to lead cross-functional teams and communicate complex safety data to stakeholders.
Highest-signal resume keywords
Pharmacovigilance LeadershipGlobal Pharmacovigilance RegulationsSignal Detection and ManagementAggregate Reporting ActivitiesTeam Development and Mentoring
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 Governance ProcessesMedical Review of Adverse EventsSafety AssessmentsBenefit-Risk EvaluationsRegulatory Safety SubmissionsInvestigator Brochures DevelopmentRisk Management PlansData AnalysisCompliance MonitoringSafety Recommendations
Soft Skills
Strong Scientific JudgmentExcellent Communication SkillsLeadership ExperienceInfluencing StakeholdersCollaboration
Certifications & Qualifications
MDMD PhDMD MPH
Industry Keywords
Pharmaceutical IndustryDrug DevelopmentFDAEMAICHSafety Management TeamHealth Authority InspectionsQuality AssessmentsClinical DevelopmentRegulatory Affairs
About the role
Key responsibilities & impact- Provide strategic and medical leadership for global safety surveillance and risk management activities across investigational and marketed products
- Lead development and improvement of pharmacovigilance policies, procedures, and safety governance processes
- Ensure compliance with global pharmacovigilance regulations and reporting requirements
- Lead signal detection and signal management activities
- Conduct and oversee medical review of serious adverse events, adverse events of special interest, and individual case safety reports
- Chair Safety Management Team meetings and safety governance forums
- Author, review, and approve safety assessments, benefit-risk evaluations, signal evaluation reports, and safety recommendations
- Oversee aggregate safety reports and regulatory safety submissions, including DSURs, PBRERs/PSURs, IND annual reports, expedited safety reports, integrated summaries of safety, and marketing application documents
- Direct development and maintenance of Investigator Brochures, Reference Safety Information, Company Core Data Sheets, Safety Management Plans, and Risk Management Plans
- Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Clinical Operations
- Collaborate with alliance partners, licensors, CROs, and external vendors
- Represent Drug Safety and Pharmacovigilance in governance committees, development teams, due diligence evaluations, and regulatory interactions
- Build, develop, and mentor a high-performing pharmacovigilance team
- Ensure inspection readiness and support health authority inspections, partner audits, and internal quality assessments
- Monitor emerging regulatory requirements, industry trends, and best practices
- Review scientific and medical literature for safety assessments and benefit-risk evaluations
- Contribute to corporate development activities, including due diligence, asset evaluations, and integration planning
Requirements
What you’ll need- MD, MD PHD, or MD MPH required
- 12+ years pharmaceutical industry experience in pharmaceutical drug development, including significant experience in pharmacovigilance and drug safety leadership
- Deep understanding of global pharmacovigilance regulations, including FDA, EMA, ICH, and other regional requirements
- Demonstrated experience leading safety surveillance, signal detection, risk management, and aggregate reporting activities for investigational and/or marketed products
- Strong scientific and clinical judgment with the ability to evaluate complex safety data and communicate benefit-risk assessments effectively
- Proven leadership experience managing teams and influencing cross-functional stakeholders in a matrix environment
- Excellent written and verbal communication skills with experience presenting to senior leadership, governance committees, regulators, and external partners
Benefits
Comp & perks- Equity in the form of stock options and/or restricted stock units
- Comprehensive health, dental, vision, life and disability insurance coverage
- 401k retirement benefits with employer match
- Learning stipends
- Wellness stipends
- Paid time off