Associate II, Patient Safety Solutions
5 days 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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