Job Overview
Location
2 Locations
Job Type
Full-time
Category
Other
Date Posted
April 22, 2026
Full Job Description
đź“‹ Description
- • The Associate II, Patient Safety Solutions role is critical to ensuring patient safety through the accurate and timely processing of adverse event reports from clinical trials and post-marketing sources, directly supporting regulatory compliance and public health protection.
- • Day-to-day responsibilities include triaging incoming adverse event cases, performing duplicate checks, creating and initiating cases in the Oracle Argus safety database, assessing validity, seriousness, expectedness, and causality using the WHO-UMC system, conducting medical adjudication in coordination with medical reviewers, entering safety data, coding adverse events using MedDRA, identifying missing information, conducting telephone queries to healthcare providers or reporters, resolving discrepancies with vendors and partners, notifying Quality Assurance of potential quality issues, maintaining up-to-date knowledge of SOPs and regulatory guidance, supporting root cause analysis and CAPA development, participating in audits and inspections, and demonstrating core competencies and company values while building strong cross-functional relationships.
- • Fortrea Holdings Inc. is a global leader in clinical research and patient safety solutions, dedicated to advancing healthcare through rigorous safety monitoring and regulatory compliance. The company operates with a strong commitment to quality, integrity, and innovation in pharmacovigilance, serving clients across the pharmaceutical and biotechnology industries.
- • In this role, you will deepen your expertise in global pharmacovigilance processes, gain hands-on experience with the Oracle Argus safety system and MedDRA coding, strengthen your understanding of ICH guidelines and U.S. regulatory requirements, develop advanced case assessment and causality analysis skills, and build valuable experience in quality assurance, audit support, and cross-functional collaboration—positioning you for growth into senior safety or regulatory affairs roles.
🎯 Requirements
- • Associate’s degree in Nursing (RN) plus 1–2 years of safety experience, or a BS/BA plus 2 years of minimum safety experience
- • Minimum of two years of pharmacovigilance (PV) work experience in Canada or the U.S.
- • Proven expertise in processing U.S. post-approval adverse event cases
- • Proficiency with the Oracle Argus safety database
- • Advanced command of English language (speaking, writing, and reading)
- • Strong attention to detail with a high degree of accuracy
🏖️ Benefits
- • Competitive annual pay range of CAD 67,000–82,000
- • Fully remote, home-based position based in Canada
- • Flexible hours to accommodate business needs
- • Opportunity to work with a global leader in clinical research and patient safety
- • Exposure to industry-standard safety databases (Oracle Argus) and regulatory frameworks (ICH, MedDRA, WHO-UMC)
- • Support for professional development through involvement in audits, inspections, CAPA, and root cause analysis
Skills & Technologies
About Fortrea Holdings Inc.
Fortrea is a global contract research organization spun out from LabCorp in 2023 to provide drug development services across Phases I-IV. It offers clinical trial management, patient access solutions, regulatory consulting, and commercialization support to biopharmaceutical, medical device, and diagnostic clients. The company operates in more than 90 countries with 19,000 employees, leveraging therapeutic expertise in oncology, rare diseases, neuroscience, and other complex areas to accelerate therapies from lab to market while prioritizing patient experience and data-driven insights.
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