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Senior Director, Pharmacovigilance, Drug Safety
Everest Clinical ResearchSenior Director of Pharmacovigilance overseeing drug safety operations and compliance at Everest Clinical Research. Managing post-marketing services on a global scale from our remote office in Canada.
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- direct the operational delivery of clinical trial safety services
- ensure all active clinical trials meet client-specific Service Level Agreements (SLAs)
- oversee the timely preparation and distribution of Investigator Letters and expedited safety reports
- lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure
- formulate the roadmap to expand post-marketing services globally
- author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs)
- establish operational workflows for global literature screening and localized digital media safety monitoring
- ensure compliance with expedited reporting timelines
Requirements
What you’ll need- PharmD, MD, PhD, or a Master’s degree in a life sciences or nursing discipline
- minimum 10 years of progressive experience in drug safety/pharmacovigilance within a CRO or pharmaceutical setting
- at least 5 years in a CRO leadership role
- demonstrated, hands-on experience managing both clinical trial safety operations and FDA post-marketing case processing
- profound understanding of FDA regulations (21 CFR 312, 314, 600), ICH guidelines, and global GVP modules
- proven experience building, scaling, or launching a new functional capability or service line within a life sciences organization
- deep expertise in validated safety databases (Oracle Argus preferred) supporting multi-tenant configurations and global reporting destinations
Benefits
Comp & perks- medical, dental, and vision coverage
- life & AD&D insurance
- short- and long-term disability
- tuition reimbursement
- fitness reimbursement
- employee assistance program (EAP)
- a pension plan
- generous paid time off and sick leave
- opportunity to earn a performance based bonus
ATS Keywords
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Hard Skills & Tools
Clinical Trial Safety OperationsPost-Marketing Case ProcessingService Level Agreements (SLAs)Standard Operating Procedures (SOPs)Global Literature ScreeningDigital Media Safety MonitoringOperational WorkflowsSafety Reporting TimelinesPharmacovigilanceRegulatory Compliance