Senior Director, Pharmacovigilance and Drug Safety
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.
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:
- 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.
- 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.
- 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.
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:
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: