Fortrea, a leading global contract research organization (CRO) known for its scientific rigor and decades of clinical development experience, is seeking a Safety Science Analyst. This role involves managing the receipt and processing of all adverse event reports from clinical trials, ensuring safety database entry, adverse event review, patient narrative writing, and follow-up on missing information.
Key Responsibilities:
- Manage the receipt and processing of adverse event reports from clinical trials, including safety database entry, adverse event review, patient narrative writing with coding, and follow-up on missing information.
- Submit expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, Partners, and Fortrea project personnel, as required and agreed upon during study setup.
- Ensure prioritization and timely submission of cases requiring expedited reporting to worldwide Regulatory Agencies or other recipients within the regulatory and/or study-specific timelines.
- Write patient narratives and accurately code adverse events using MedDRA.
- Perform peer/independent quality control (QC) of safety reports as needed.
- Collaborate with Data Management or clients on the reconciliation of safety databases, if appropriate.
- Identify and ensure the collection of clinically significant information missing from reports; prepare follow-up correspondence in consultation with medical staff, as needed.
- Actively participate in project team and client meetings and liaise with clients as appropriate.
