Associate II Patient Safety Solutions; PSS) Remote 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

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.

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.

• 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.

• 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.

• 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…