Associate II Patient Safety Solutions - Remote (Canada)

About the Role

Fortrea is hiring an Associate II for Patient Safety Solutions, a fully remote position based in Canada requiring a comprehensive clinical background and familiarity with the US Healthcare environment. This full-time role involves managing adverse event case processing for clinical trials and post-approval product monitoring.

Key Responsibilities

• Handle the intake and processing of all adverse event reports, whether reported spontaneously or from clinical trials.
• Prioritize incoming cases for daily workflow, conduct medical adjudication evaluating event validity, seriousness, expectedness, and causality using WHO-UMC criteria in collaboration with the medical review team.
• Enter safety data into adverse event databases and tracking systems.
• Review adverse event reports for completeness, correctness, and suitability for expedited reporting.
• Draft patient narratives, precisely code adverse events using MedDRA, and assess listedness against product labels for marketed products.
• Identify and pursue collection of missing clinically significant information.
• Ensure timely processing of cases requiring expedited reporting to global regulatory agencies.
• Maintain thorough knowledge of SOPs, Work Instructions, guidance documents, and directives related to safety surveillance and pharmacovigilance.
• Contribute to root cause analyses and support CAPA plan creation and execution for quality concerns.
• Assist in audit and inspection preparation and participation.
• Consistently demonstrate core competencies and uphold company values while fostering positive internal relationships.
• Perform other duties as assigned.

Minimum Qualifications and Experience

• Education: Associate's degree in Nursing plus two years’ safety experience, or Bachelor's/Master’s degrees or PharmD with minimum one year safety experience.
• Safety experience includes processing AE/SAE reports, narrative writing, query management, workflow in safety databases, and regulatory submission participation.
• At least two years pharmacovigilance experience in Canada or US.
• Fluent English skills in reading, writing, and speaking.
• Mandatory experience with US post-approval case processing.
• Proficient in Argus safety database usage.
• Strong typing and familiarity with Microsoft Office and Windows environments advantageous.
• Meticulous attention to detail and high accuracy.
• Ability to work autonomously with limited supervision.
• Good understanding of ICH guidelines and global regulatory requirements concerning adverse event reporting for marketed and investigational drugs.

Work Environment and Physical Demands

• Primarily office-based with regular use of electrical office equipment.
• Occasional travel domestically and internationally, including travel to site locations.
• Typically seated for 6-8 hours daily with repetitive hand and wrist movements required.
• Occasional physical activities such as crouching, bending, twisting, and light to moderate lifting up to 15-20 lbs.
• Regular attendance expected; flexible hours may be needed.

Compensation and Benefits

The salary ranges from CAD 67,000 to 82,000 annually, dependent on skills, experience, education, and market considerations.

Additional Information

Fortrea complies with health and safety legislations including Health & Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3. The company promotes equal employment opportunity and accommodates requests as needed.

Application deadline: August 10, 2026.