Associate II, Patient Safety Solutions
19 hours ago
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.
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