Safety Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Safety Lead based in Canada. This is a senior clinical safety and pharmacovigilance leadership opportunity within a global, fast-paced environment. You will provide safety expertise across clinical programs, supporting clients, study teams, vendors, and internal stakeholders. The role spans safety planning, serious adverse event oversight, regulatory reporting, quality management, and inspection readiness. You will serve as a subject matter expert while helping shape processes, training, and operational standards across the function. The position combines hands-on safety expertise with project leadership, cross-functional collaboration, and client engagement. You will also mentor Safety Specialists and contribute to departmental initiatives and continuous improvement. Success requires sound clinical judgment, strong regulatory knowledge, excellent communication, and the ability to operate effectively in complex environments. Lead and oversee safety activities across clinical projects, including project kickoffs, study meetings, governance meetings, and client interactions. Develop and review project-specific safety management, reporting, and medical coding plans, ensuring alignment with applicable requirements. Oversee serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) case management from intake through regulatory reporting. Partner with sponsors, vendors, study teams, and internal stakeholders to design and implement effective safety collection tools, processes, and reporting systems. Participate in the assessment and setup of safety databases and oversee processes for capturing, reviewing, and reporting safety data. Conduct quality control and review of safety documents, reports, training materials, and other pharmacovigilance deliverables. Develop and maintain standard operating procedures, work instructions, and other departmental safety processes. Provide subject matter expertise on clinical safety and pharmacovigilance matters to clients, project teams, and departmental colleagues. Provide training, coaching, and mentorship to Safety Specialists while supporting departmental resource management and oversight. Support audits, inspection readiness, investigator meetings, audit preparation, and regulatory agency inspections, including activities related to BLA or NDA approval inspections. Participate in CAPA management and support the development and implementation of corrective and preventive actions. Support bid defenses, client proposals, and safety-related project discussions by providing technical and operational expertise. Lead standalone safety projects and contribute to cross-functional initiatives and departmental improvements. Oversee SAE/AESI queries, tracking, escalation, and resolution, and provide input on responses to regulatory agency questions related to safety and pharmacovigilance. Identify opportunities to strengthen safety processes, systems, and delivery while ensuring high standards of quality and compliance. Requirements: Bachelor’s degree in a relevant field, with a healthcare professional background required. 10+ years of clinical safety experience and at least 5 years of pharmacovigilance experience. Hands-on experience with global safety databases, SAE case processing, and safety report generation. Strong knowledge of MedDRA, WHODrug, FDA safety regulations, ICH guidelines, and applicable global regulatory requirements. Demonstrated understanding of clinical trial safety reporting and pharmacovigilance processes across relevant regulatory environments. Experience supporting internal audits, inspection readiness, and regulatory agency inspections within clinical research environments. Ability to understand complex clinical and safety issues and communicate them clearly and scientifically to technical and non-technical audiences. Excel