Fortrea is currently seeking a US 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 (non-exempt) full-time, home-based position in the USA that will require willingness to work flexible hours as needed to meet business needs.

WHAT YOU WILL DO

As a member of our Patient Safety Services (PSS) team, you will play a key role in supporting safety operations across a key project portfolio. This includes performing ICSR case processing, encompassing safety data from clinical trials and post-marketing settings (e.g., unsolicited reports).

In this role, you will ensure timely, accurate, and compliant handling of safety information while delivering high-quality service to both internal and external stakeholders. Your work will help maintain patient safety and regulatory compliance in a cost-effective and efficient manner.

Summary of Responsibilities:

• Manage the receipt and processing of all adverse event reports, whether reported spontaneously from any source or originating from clinical trials. This includes, but is not limited to:
  • Perform accurate data entry of safety information into adverse event databases and tracking systems. 
  • Review adverse event reports for completeness, accuracy and appropriateness for expedited reporting.
  • Draft patient narratives, code adverse events using MedDRA terminology, and determine listedness against the appropriate product label (for Marketed products, if applicable).
  • Identify missing clinically significant information and ensure timely collection and follow-up.
  • Ensure all cases requiring expediting reporting to global Regulatory Agencies and other stakeholders are processed properly and incompliance with required timelines.

• Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives relative to safety management, reporting and pharmacovigilance.
• Support root cause analysis and contribute to the development and implementation of Corrective and Preventative Action (CAPA) plans for identified quality issues as needed.
• Assist with and/or participate in audits and inspections including preparation activities as required.
• Consistently demonstrate role-specific Core Competencies and uphold company values.   Foster strong relationships within PSS team and across functional units.
• And all other duties as assigned.

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 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
• 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.

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: USD $27.50 - $35.00 / hourly rate

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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).

Application Deadline: 01/24/26

Learn more about our EEO & Accommodations request here.