Salary :
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Pharmacovigilance and Drug Safety based in Canada.
This leadership role offers the opportunity to shape and expand global pharmacovigilance and drug safety capabilities within a fast-growing clinical research environment.
You will oversee critical safety operations across clinical trials while driving the development of post-marketing safety infrastructure.
The position combines strategic leadership, operational excellence, regulatory expertise, and commercial growth responsibilities.
You will collaborate with cross-functional teams, sponsors, and scientific experts to ensure high-quality safety deliverables.
This role requires a strong understanding of global regulatory frameworks and the ability to build scalable safety processes.
As a senior leader, you will influence business growth while advancing patient safety standards across international markets.
Accountabilities:
The Senior Director, Pharmacovigilance and Drug Safety will lead the delivery, expansion, and continuous improvement of safety services while ensuring regulatory compliance, operational efficiency, and client satisfaction. Key responsibilities include:
- Oversee clinical trial pharmacovigilance operations, including Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) processing, medical review, tracking, and reporting activities.
- Ensure clinical trial safety programs meet sponsor requirements, Service Level Agreements (SLAs), Key Performance Indicators (KPIs), and Safety Management Plans (SMPs).
- Lead the preparation and distribution of investigator communications, expedited safety reports, and safety data packages for monitoring committees.
- Design and implement post-marketing safety infrastructure, including safety databases, case processing workflows, and global pharmacovigilance capabilities.
- Develop strategic roadmaps to expand safety services across international markets, supporting multilingual intake processes, regional regulatory requirements, and global reporting standards.
- Create and implement Standard Operating Procedures (SOPs) and Safety Data Exchange Agreement (SDEA) frameworks aligned with FDA requirements, ICH guidelines, and global Good Pharmacovigilance Practices (GVP).
- Establish operational capabilities for literature monitoring, digital media safety surveillance, and aggregate safety reporting.
- Ensure compliance with expedited regulatory submissions, including FDA reporting timelines and global electronic safety transmissions.
- Partner with regulatory, medical writing, and scientific teams to support the preparation of periodic safety documents such as DSURs, PADERs, and PBRERs.
- Support business development initiatives by contributing to proposals, capability presentations, client discussions, and strategic growth opportunities.
- Manage financial performance, resource planning, utilization, and profitability for the safety services portfolio.
- Build and mentor high-performing teams while fostering operational excellence and continuous improvement.
Requirements:
The ideal candidate brings extensive pharmacovigilance leadership experience, strong regulatory expertise, and the ability to develop scalable safety operations in a global environment. Required qualifications include:
- Advanced degree in a relevant scientific discipline, such as PharmD, MD, PhD, or a Master’s degree in life sciences or nursing.
- Minimum 10 years of progressive experience in drug safety and pharmacovigilance within a pharmaceutical, biotechnology, or clinical research organization environment.
- At least 5 years of leadership experience managing pharmacovigilance operations or safety service teams.
- Demonstrated expertise across both clinical trial safety operations and post-marketing safety case processing.
- Strong knowledge of FDA regulations, including 21 CFR 312, 314, and 600, along with ICH guidelines and global Good Pharmacovigilance Practices (GVP).
- Proven experience building, scaling, or launching new pharmacovigilance capabilities or service lines.
- Deep understanding of validated safety databases, including experience with Oracle Argus or similar pharmacovigilance systems.
- Strong leadership, strategic thinking, stakeholder management, and communication skills.
- Ability to manage complex projects, balance business priorities, and deliver high-quality results in a dynamic environment.
Benefits:
- Competitive estimated salary range of $180,000 - $200,000.
- Comprehensive medical, dental, and vision coverage.
- Life insurance and accidental death & dismemberment (AD&D) coverage.
- Short-term and long-term disability benefits.
- Tuition reimbursement and professional development support.
- Fitness reimbursement and employee assistance program (EAP).
- Pension plan and retirement support.
- Generous paid time off and sick leave.
- Performance-based bonus opportunities.
- Flexible remote work options available from anywhere in Canada.
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