Associate 2 Patient Safety Solutions Remote Based in Canada

**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** #LI-SE1 Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).