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