Senior Director, Pharmacovigilance and Drug Safety

Job summary

Direct the operational delivery of clinical trial safety services and lead the strategic expansion of post-marketing safety infrastructure from the US to a global scale. Manage regulatory submissions, aggregate reporting, and the financial performance of the safety business unit.

Job details

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. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. 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. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. 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 1. Clinical Trial PV Operations & Oversight 1. Trial Safety Management: 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). 2. Sponsor Delivery: Ensure all active clinical trials meet client-specific Service Level Agreements (SLAs), Key Performance Indicators (KPIs), and Safety Management Plans (SMPs). 3. Investigator & Committee Support: Oversee the timely preparation and distribution of Investigator Letters, expedited safety reports, and data feeds for Data Monitoring Committees (DMCs/DSMBs). 2. Phased Strategic Portfolio Expansion (US to Global Post-Marketing) * 1. Phase 1 Infrastructure (US Focus): 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. 2. Phase 2 Infrastructure (Global Scale): 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. 3. SOP & SDEA 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). 4. Capabilities Building: Establish operational workflows for global literature screening, localized digital media safety monitoring, and multi-regional aggregate report compilation. 1. Regulatory Submissions & Aggregate Reporting * 1. Expedited Submissions: 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). 2. Aggregate Document Delivery: 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). 1. Commercial Growth & Financial Leadership * 1. Business Development: 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. 2. P&L Ownership: Manage the financial performance, utilization rates, and profit margins of the safety business unit, balancing headcount across clinical trials and expanding post-marketing pipelines. Minimum Qualifications * 1. Education: PharmD, MD, PhD, or a Master’s degree in a life sciences or nursing discipline. 2. 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. 3. Dual Portfolio Expertise: Demonstrated, hands-on experience managing both clinical trial safety operations and FDA post-marketing case processing. 4. 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. 5. 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. 6. Systems Mastery: Deep expertise in validated safety databases (Oracle Argus preferred) supporting multi-tenant configurations and global reporting destinations. Benefits & Compensation: We offer a robust benefits package to support your 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), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $180,000 - $200,000. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com [http://www.everestclinical.com] We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-KD1

What you’ll do

Direct the operational delivery of clinical trial safety services and lead the strategic expansion of post-marketing safety infrastructure from the US to a global scale. Manage regulatory submissions, aggregate reporting, and the financial performance of the safety business unit.

Requirements

Requires a postgraduate degree (PharmD, MD, PhD, or Master's) and at least 10 years of drug safety experience, including 5 years in a CRO leadership role. Must have demonstrated expertise in both clinical trial and FDA post-marketing safety operations and mastery of validated safety databases like Oracle Argus.

Benefits

• Medical Coverage • Dental Coverage • Vision Coverage • Life Insurance • AD&D Insurance • Short-term Disability • Long-term Disability • Tuition Reimbursement • Fitness Reimbursement • Employee Assistance Program (EAP) • Pension Plan • Paid Time Off • Sick Leave • Performance Based Bonus

Listed skills

• Architectural Design · Preferred
• Organization · Preferred
• Leadership · Preferred
• Client · Preferred
• safety · Preferred
• management · Preferred
• Reporting · Preferred
• Development · Preferred
• Oracle · Preferred
• Time · Preferred
• Customer · Preferred
• Business development · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Pharmacovigilance
• Drug Safety
• Clinical Trial Safety Management
• Post-Marketing Safety
• Regulatory Submissions
• Aggregate Reporting
• Oracle Argus
• Business Development
• P&L Management
• SOP Development
• SDEA Frameworks
• FDA Regulations
• ICH Guidelines
• GVP Modules
• Case Processing
• Clinical Research Operations

Job areas

• Healthcare
• Science & Research
• Management & Leadership
• Consulting