Associate II, Patient Safety Solutions, Remote

Overview

Fortrea is currently seeking an 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.

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 solicited from a clinical trial. This includes, but is not limited to:

• Triage of incoming cases to prioritize for daily workflow management.
• Perform duplicate checks and single case creation/initiation in the Oracle Argus safety database.
• Perform validity, seriousness, expectedness/labeledness/listedness and determine causality using the WHO
  -UMC system.
• Perform medical adjudication of incoming cases for the event seriousness in coordination with the medical review team.
• Data entry of safety data onto adverse event database(s) and tracking systems
• Review and coding of adverse events using MedDRA for completeness, accuracy and appropriateness for expedited reporting.
• Identify clinically significant information missing from the reports and ensure its collection.
• Perform urgent telephone queries to the reporter/HCP to clarify the missing or incomplete information.
• Identify any discrepancies in the reports and send the appropriate queries to the vendors and the partners for further resolution.
• Identify potential quality issues and send appropriate notifications to the Quality Assurance team for further investigation.
• 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 for identified quality issues, as needed.
• Support and/or participate in audits and inspections, as needed.
• Demonstrate role-specific Core Competencies and company values on a consistent basis ¨ Build and maintain good PSS relationships across functional units.
• All other duties as needed or assigned.

• Associate’s degree RN + 1-2 years of safety experience*
• BS/BA + 2 years of minimum safety experience*
• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

• 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 is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

• 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.

CAD 67,/annually

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.

02/25/26

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