The Associate II, Patient Safety Solutions will manage adverse event reporting and ensure compliance with regulatory timelines.

Key Responsibilities:

• Process and review adverse event reports from clinical trials and post-marketing 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 tracking systems, project documentation, and support audits and inspections.
• Collaborate with clients and mentor team members as needed.

What you need to bring:

• Degree in Life Sciences or related field preferred.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• 2+ years of pharmacovigilance or safety experience
• Strong attention to detail, communication skills, and ability to work independently
• Proficiency in MS Office and safety databases

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 stationery 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 .