Everest Clinical Research logo
Everest Clinical Research

Quality is Our Backbone. Customer-focus is Our Tradition. Flexibility is Our Strength.

Senior Director, Pharmacovigilance, Drug Safety

DirectorDirectorFull TimeRemoteSeniorTeam 501-1,000Since 2004H1B SponsorCompany SiteLinkedIn

Location

Canada

Posted

21 hours ago

Salary

$180K - $200K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglishOracle

Job Description

Senior Director, Pharmacovigilance, Drug Safety

Everest Clinical Research

• 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

Job Requirements

  • 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

  • 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

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