Associate I, Patient Safety Solutions
3 days ago
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.
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