The Associate I, Patient Safety Solutions role will manage adverse event reports from multiple sources, ensuring compliance with regulatory timelines and quality standards.

Key Responsibilities

• Process and review adverse event reports from clinical trials and spontaneous sources.
• Enter safety data, write patient narratives, and code events using MedDRA.
• Ensure timely submission of expedited safety reports to regulatory authorities and clients.
• Maintain documentation, tracking systems, and support audits and inspections.
• Collaborate with clients and team members, providing training and mentoring as needed.

What You Need To Bring

• Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field preferred.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• 1+ year of safety or relevant experience (or equivalent combination of education and experience).
• Strong attention to detail, communication skills, and ability to work independently.
• Proficiency in MS Office; mentoring skills a plus.

Note: This role does not provide sponsorship. 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.

Learn more about our EEO & Accommodations request here.