Associate II, Patient Safety Solutions, Remote based in Canada - Toronto
3 days ago
Job description
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.
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 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.
Qualifications (Minimum Required):
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.
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: 02/25/26
Learn more about our EEO & Accommodations request here.
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