[Hiring] Senior Director, Pharmacovigilance and Drug Safety @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Director, Pharmacovigilance and Drug Safety for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Responsibilities

• Clinical Trial PV Operations & Oversight
  • Direct the operational delivery of clinical trial safety services, including the processing, medical review, and tracking of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
  • Ensure all active clinical trials meet client-specific Service Level Agreements (SLAs), Key Performance Indicators (KPIs), and Safety Management Plans (SMPs).
  • Oversee the timely preparation and distribution of Investigator Letters, expedited safety reports, and data feeds for Data Monitoring Committees (DMCs/DSMBs).
• Phased Strategic Portfolio Expansion (US to Global Post-Marketing)
  • Lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure, configuring multi-tenant safety databases for spontaneous, literature, and patient support program case processing.
  • Formulate the roadmap to expand post-marketing services globally, adapting systems to support multi-lingual intake, EU/UK QPPV networks, and diverse international regulatory frameworks.
  • Author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs) and Safety Data Exchange Agreement (SDEA) templates, initially aligned with FDA 21 CFR 314/600 and systematically upgraded to meet Global Good Pharmacovigilance Practices (GVP).
  • Establish operational workflows for global literature screening, localized digital media safety monitoring, and multi-regional aggregate report compilation.
• Regulatory Submissions & Aggregate Reporting
  • Ensure flawless compliance with expedited reporting timelines, including FDA 7/15-day clinical trial alerts, FDA 15-day post-marketing requirements, and global E2B(R3) electronic transmissions (FAERS, EVMPD).
  • Collaborate with Regulatory Strategy and Submissions team and with Medical and Scientific Writing service areas for the authoring and submission of periodic regulatory documents bridging pre- and post-marketing formats (e.g., DSURs, PADERs, PBRERs).
• Commercial Growth & Financial Leadership
  • Partner with Sales and Marketing to build commercial capabilities presentations, defend Requests for Proposals (RFPs), and pitch phased post-marketing capabilities to prospective pharma/biotech Sponsors.
  • Manage the financial performance, utilization rates, and profit margins of the safety business unit, balancing headcount across clinical trials and expanding post-marketing pipelines.

Qualifications

• Education: PharmD, MD, PhD, or a Master’s degree in a life sciences or nursing discipline.
• Experience: Minimum 10 years of progressive experience in drug safety/pharmacovigilance within a CRO or pharmaceutical setting, with at least 5 years in a CRO leadership role.
• Dual Portfolio Expertise: Demonstrated, hands-on experience managing both clinical trial safety operations and FDA post-marketing case processing.
• Global Regulation Command: Profound understanding of FDA regulations (21 CFR 312, 314, 600), ICH guidelines, and global GVP modules required to transition operations from US-centric to global.
• Growth Track Record: Proven experience building, scaling, or launching a new functional capability or service line (such as expanding from clinical to post-marketing) within a life sciences organization.
• Systems Mastery: Deep expertise in validated safety databases (Oracle Argus preferred) supporting multi-tenant configurations and global reporting destinations.

Benefits

• Robust benefits package to support health, well-being, and growth, including medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.

Company Description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.