Quality Assurance and Pharmacovigilance Associate (12-month contract) Hybrid – Toronto, ON

Introduction Our client, a leading organization in the life sciences industry, is seeking a Quality & Pharmacovigilance Specialist to join their team on a contract basis. This role will support quality and safety-related activities, ensuring compliance with internal procedures and applicable regulatory requirements. The successful candidate will work cross-functionally across quality, safety, regulatory, and medical teams while supporting day-to-day operational activities.

Responsibilities Support pharmacovigilance and quality processes in accordance with company procedures and regulatory requirements. Review, process, and maintain safety and quality-related documentation, ensuring accuracy and completeness. Monitor, document, and escalate product complaints, adverse events, deviations, and other quality-related incidents as required. Assist with investigations, root cause analysis, corrective and preventive actions (CAPAs), and follow-up activities. Maintain accurate records and data within relevant quality and safety management systems. Collaborate with cross-functional stakeholders, including regulatory affairs, medical affairs, quality assurance, and operations teams. Support audits, inspections, and compliance activities, including document preparation and follow-up actions. Ensure adherence to applicable regulations, guidelines, standard operating procedures, and quality standards. Respond to internal and external inquiries related to quality and product safety processes.

Requirements Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related discipline. 3–5 years of experience in pharmacovigilance, quality assurance, quality control, regulatory affairs, or related pharmaceutical/biotechnology environments. Understanding of GxP, pharmacovigilance, and/or quality management principles. Experience reviewing technical, scientific, or regulated documentation with strong attention to detail. Ability to manage multiple priorities in a fast-paced environment. Strong verbal and written communication skills. Proficiency with electronic quality, safety, or data management systems is considered an asset. Experience supporting both quality and pharmacovigilance activities within a small or mid-sized organization is considered an asset.

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