The Safety Science Specialist will manage the receipt and processing of all adverse event reports, both spontaneous and solicited from clinical trials. This role involves data entry, review of adverse events, writing patient narratives, coding adverse events, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Adverse Event Management:
- Data entry of safety data onto adverse event databases and tracking systems.
- Review adverse events for completeness, accuracy, and appropriateness for expedited reporting.
- Write patient narratives and code adverse events accurately using MedDRA.
- Determine listedness against appropriate labels for marketed products.
- Identify and collect clinically significant information missing from reports.
- Ensure cases receive appropriate medical review and are processed within required timelines.
- Report endpoints to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel.
- Submission and Reporting:
- Submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, and other required parties within specified timelines.
- Assist in database reconciliation with the Data Management team or clients.
- Manage processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Quality and Compliance:
- Perform quality review or peer review of processed reports.
- Maintain adverse event tracking systems and project documentation.
- Maintain a comprehensive understanding of SOPs, WIs, guidance documents, and directives associated with safety management and reporting.
- Support root cause analysis and CAPA plan development for identified quality issues.
- Participate in audits and inspections.
- Collaboration and Communication:
- Build and maintain good relationships across functional units.
- Support preparation for client meetings and liaise with clients as appropriate.
- Assist with the setup and provision of data to Safety Committees/DSMBs.
- Documentation and Archiving:
- Prepare and support coordination of safety study files for archiving upon project completion.