Senior Director, Pharmacovigilance, Drug Safety

This is a fully remote position, open to applicants in Canada.

📋 Description

• Direct the operational delivery of services related to clinical trial safety.

• Ensure that all ongoing clinical trials comply with client-specific Service Level Agreements (SLAs).

• Oversee the prompt preparation and distribution of Investigator Letters and expedited safety reports.

• Lead the architectural design and implementation of the CRO’s initial U.S. post-marketing safety framework.

• Develop the strategy for expanding post-marketing services on a global scale.

• Author and initiate a comprehensive suite of post-marketing Standard Operating Procedures (SOPs).

• Establish operational workflows for global literature screening and localized digital media safety monitoring.

• Ensure adherence to expedited reporting timelines.

⛳️ Requirements

• PharmD, MD, PhD, or a Master's degree in a life sciences or nursing field.

• A minimum of 10 years of progressive experience in drug safety/pharmacovigilance within a CRO or pharmaceutical environment.

• At least 5 years of experience in a leadership role within a CRO.

• Demonstrated, hands-on experience in managing both clinical trial safety operations and FDA post-marketing case processing.

• In-depth knowledge of FDA regulations (21 CFR 312, 314, 600), ICH guidelines, and global GVP modules.

• Proven experience in building, scaling, or launching a new functional capability or service line within a life sciences organization.

• Extensive expertise in validated safety databases (preferably Oracle Argus) that support multi-tenant configurations and global reporting destinations.

🏝️ Benefits

• 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.