Senior Director, Pharmacovigilance, Drug Safety

Everest Clinical Research

Senior 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.

Posted 7/9/2026full-timeRemote • 🇨🇦 CanadaSenior💰 $180,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in clinical trial safety operations and FDA post-marketing case processing, with a strong focus on compliance with FDA regulations and ICH guidelines. Proven ability to lead and scale safety services within a life sciences organization, ensuring adherence to Service Level Agreements and operational workflows.

Highest-signal resume keywords

PharmD, MD, PhD, or Master’s Degree in Life Sciences10+ Years in Drug Safety/Pharmacovigilance5+ Years in CRO Leadership RoleExpertise in FDA Regulations (21 CFR 312, 314, 600)Experience with Oracle Argus Safety Database

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Safety OperationsPost-Marketing Case ProcessingService Level Agreements (SLAs)Standard Operating Procedures (SOPs)Global Literature ScreeningDigital Media Safety MonitoringOperational WorkflowsSafety Reporting TimelinesPharmacovigilanceRegulatory Compliance

Tools & Technologies

Oracle Argus

Industry Keywords

CROLife SciencesFDAICH GuidelinesGlobal GVP Modules

Tech Stack

Tools & technologies

Oracle

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