- Perform case intake and triage of incoming safety information or reports from various sources, either spontaneously or from a clinical trial.
- Assist with processing adverse events, including but not limited to:
- Data entry of safety data onto adverse event tracking systems.
- Writing patient narratives and accurately coding adverse events using MedDRA (for Marketed products, if applicable).
- Assisting in the listedness assessment against the appropriate label (for Marketed products, if applicable).
- Generating queries and collecting missing or discrepant information in consultation with medical staff, if needed.
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel as required within the agreed timelines.
- Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel, etc.), and prioritize reports for processing and submission within regulatory and/or study-specific applicable timelines.
- Assist in the reconciliation of databases, as applicable.
- Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs), etc., as appropriate.
- Assist in maintaining supporting files/documentation regarding adverse event reporting requirements in all countries, if applicable.
- Support upload/archival of case/study/project documentation, as appropriate.
- Build and maintain good PSS relationships across functional units.
- Support compliance of operations with governing regulatory requirements.
- Perform all other duties as needed or assigned.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea,