Associate 2 Patient Safety Solutions Remote Based in Canada

**Job Title:** Associate II Patient Safety Solutions (PSS) Remote based in Canada **Job Location:** Toronto **Job Location Type:** Remote **Job Contract Type:** Full-time ### Job Seniority Level: ### **Associate II, Patient Safety Solutions** ### **Remote Based in Canada** Fortrea is currently seeking a remote based **Associate II (Patient Safety Solutions)** to perform clinical trial and post approval adverse event case processing. This role requires strong clinical knowledge as well as an understanding of the US Healthcare system. **This is a full-time, home-based position in Canada that will require willingness to work flexible hours as needed to meet business needs.** ### WHAT YOU WILL DO You will be responsible for assisting with overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). In addition, you will be responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. You will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual. ### Summary of Responsibilities: * **Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:** * Triage of incoming cases to prioritize for daily workflow management, including performing medical adjudication for event validity/seriousness/expectedness/listedness/causality using the WHO-UMC system in coordination with the medical review team. * Data entry of safety data onto adverse event database(s) and tracking systems. * Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. * Write patient narratives, code adverse events accurately using MedDRA and determine listedness against appropriate label (for Marketed products, if applicable). * Identify clinically significant information missing from the reports and ensure its collection and follow-up * Ensure all cases that requiring expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. * Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. * Support root cause analysis and CAPA plan development & implementation for identified quality issues as needed. * Support and/or participate in audits and inspections including the preparation as needed. * Demonstrate role-specific Core Competencies and company values on a consistent basis. Build and maintain good PSS relationships across functional units. * Undertake any other duties as needed. ### Qualifications (Minimum Required): * Associate’s degree RN + 2 years of Safety experience \* * BS/BA + 1 years of Safety experience \* * MS/MA + 1 years of Safety experience \* * PharmD + 1 years of Safety experience \* \*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. _Fortrea may consider relevant and equivalent experience in lieu of educational requirements._ ### Experience (Minimum Required): * Minimum of two years of pharmacovigilance (PV) work experience in Canada / US. * Advanced command of English language, including speaking, writing, and reading. * Proven expertise in processing U.S. post-approval cases is mandatory * Proficient with the Argus safety database. * Strong typing ability and familiarity with Microsoft Office Suite and Windows environment is advantageous. * Strong attention to detail with a high degree of accuracy. * Ability to work independently with minimal supervision * Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products. ### Work Environment: * Work is performed in an office environment with exposure to electrical office equipment. * Occasional drives to site locations with occasional travel both domestic and international. ### Physical Requirements: * Frequently stationary for 6-8 hours per day. * Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. * Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. * Ability to access and use a variety of computer software developed both in-house and off-the-shelf. * Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. * Regular and consistent attendance. * Varied hours may be required. **Pay Range:** CAD 67,000-82,000/ annually **Benefits:** All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. ### Application Deadline: August 10, 2026 Learn more about our EEO & Accommodations request here. ### This job is curated by [Lifelancer](https://himalayas.app/companies/lifelancer). **[Lifelancer](https://himalayas.app/companies/lifelancer) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.** **Please apply via [Lifelancer](https://himalayas.app/companies/lifelancer) platform to get connected to the application page and to find similar roles.** Originally posted on [Himalayas](https://himalayas.app)