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Safety Operations Coordinator
1 week ago
About the Role:
F ortrea is seeking an experienced Safety Operations Coordinator to join their team. This role involves assisting with the overall clinical safety and operations associated with products, including managing and processing expeditable adverse events to the required standard and submitting them to the client and/or regulatory agencies within agreed timelines.
Duties and Responsibilities:
- Perform case intake and triage of incoming safety information or reports from various sources.
- Process adverse events, including data entry onto adverse event tracking systems, writing patient narratives, and coding adverse events accurately using MedDRA.
- Assist in generating queries and collecting missing or discrepant information in consultation with medical staff.
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and other recipients within agreed timelines.
- Work within the Quality Management System framework, including Standard Operating Procedure (SOP) and departmental Work Instructions (WIs).
What We're Looking For:
- At least 6 months of experience in safety, preferably with exposure to adverse event reporting and processing.
- Ability to work accurately and efficiently in a fast-paced environment.
- Strong communication and interpersonal skills.
