Quality and Patient Safety Associate

Job summary

Support pharmacovigilance, quality, and patient safety processes by reviewing documentation, maintaining records, and monitoring and escalating complaints, adverse events, deviations, and other incidents. Assist with investigations, CAPAs, audits, inspections, and compliance activities while coordinating with cross-functional teams.

Job details

Quality and Patient Safety Associate (12-month contract) Remote – Toronto, ON Introduction Our client, a leading organization in the pharmaceutical industry, is seeking a Quality & Patient Safety Associate to join their team on a 12-month contract basis. This role will support quality assurance, quality control, and patient safety activities, ensuring compliance with internal procedures and applicable regulatory requirements. The successful candidate will work cross-functionally with Quality, Pharmacovigilance, Regulatory Affairs, and Medical Affairs teams while supporting day-to-day operational and compliance-related activities. This position is fully remote, with the expectation of attending the office approximately once per month. 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. 5+ years of experience across patient safety, quality assurance, and quality control, within pharmaceutical/biotechnology environments. Demonstrated experience in project management, including planning, execution, and coordination of cross-functional activities. Experience managing change controls, deviations, and supporting internal and external audits within a regulated environment. 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. What We Offer Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job. About Us Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

What you’ll do

Support pharmacovigilance, quality, and patient safety processes by reviewing documentation, maintaining records, and monitoring and escalating complaints, adverse events, deviations, and other incidents. Assist with investigations, CAPAs, audits, inspections, and compliance activities while coordinating with cross-functional teams.

Requirements

Requires a bachelor's degree in a relevant life sciences discipline and at least five years of experience across patient safety, quality assurance, and quality control in pharmaceutical or biotechnology environments. Candidates should have project management experience, familiarity with GxP and pharmacovigilance or quality management principles, and experience with change controls, deviations, audits, and regulated documentation.

Listed skills

• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Quality Control · Preferred
• Root Cause Analysis · Preferred
• Project management · Preferred
• Cross-Functional Coordination · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Pharmacovigilance
• Quality Assurance
• Quality Control
• Patient Safety
• Regulatory Compliance
• Documentation Review
• Product Complaint Management
• Adverse Event Reporting
• Deviation Management
• Root Cause Analysis
• Corrective And Preventive Actions
• Change Control
• Audit Support
• Project Management
• Cross-Functional Coordination
• Electronic Quality Management Systems

Job areas

• Healthcare
• Science & Research
• Security & Safety
• Manufacturing
• Management & Leadership

More jobs from Brunel