Associate II, Post Approval / Case Processing - Remote based in Canada

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. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.

Other Key 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:
• 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.
• Ensure all cases that require expediting reporting to worldwide regulatory agencies and other required parties are processed swiftly and appropriately within required timelines.
• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, 3rd party vendor, Partner and Fortrea project personnel, if required, within study specified timelines.
• Manage processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, includes but not limited to:
• Maintenance of adverse event tracking systems.
• Maintains 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 the 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 required.
  
  

YOU NEED TO BRING…

• Qualifications (Minimum Required):
• Associate’s degree RN + 4 years of safety experience*
• BS/BA + 4 years of safety experience*
• MS/MA + 4 years of safety experience*
• PharmD + 4 years safety experience*
• POST APPROVAL AND CASE PROCESSING EXPERIENCE a MUST
• *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions. Degree and work experience should be in a scientific / medical field in addition to Safety Experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language skills: English proficient in speaking, writing, and reading.
• High degree of accuracy with attention to detail.
• Ability to work independently with minimal supervision.
• Good keyboard skills with knowledge of MS Office and Windows application would be beneficial.
• Training and mentoring skills preferred.
  

Learn more about our EEO & Accommodations request here.