Patient Safety and Pharmacovigilance Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Patient Safety and Pharmacovigilance Specialist based in Canada.

The Patient Safety and Pharmacovigilance Specialist is responsible for coordinating international adverse event reporting and pharmacovigilance activities in accordance with applicable regulatory requirements. You will support drug safety operations across clinical trial sites worldwide, helping ensure the accuracy, quality, and compliance of safety information. The role combines safety report assessment, regulatory submissions, performance monitoring, and continuous process improvement. You will also contribute to audit and inspection readiness, provide training, and support cross-functional teams on pharmacovigilance matters. Working in a global clinical research environment, you will help strengthen patient safety practices and support the responsible development and access to new treatments.

Accountabilities

• Monitor the pharmacovigilance system and prepare monthly performance reports to assess regulatory compliance and process effectiveness.
• Prepare, analyze, and report pharmacovigilance metrics, including KPIs, quality incidents, CAPAs, audit findings, and inspection outcomes.
• Compile and trend compliance data, perform root cause assessments and gap analyses, and evaluate the effectiveness of corrective and preventive actions.
• Review safety reports and clinical study documentation to ensure completeness, accuracy, and clinical relevance.
• Support audit and inspection readiness, including participation in internal audits and health authority inspections.
• Provide training on adverse event reporting and participate in internal and external meetings as required.
• Manage the safety mailbox, assess...

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