Summary of Responsibilities:
- Assist in the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems.
- Set up and maintain project files and central documentation files.
- Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel within study-specific timelines.
- Log incoming Adverse Event (AE)/Serious Adverse Event (SAE) reports into the departmental tracking system and forward them to the centralized mailbox.
- Assist with processing adverse events, including data entry of safety data, writing patient narratives, coding adverse events using MedDRA, and performing listedness assessments (for marketed products, if applicable).
- Generate queries to collect missing or discrepant information in consultation with medical staff.
- Submit expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, partners, and Fortrea project personnel within the agreed timelines.
- Assist with peer/quality review of processed reports and support with trend analysis and actions as needed.
- Reconcile databases, as applicable, and maintain files regarding adverse event reporting requirements in all countries.
- Work within the Quality Management System framework, including adhering to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Prepare and support the coordination of safety study files for archiving upon project completion.
- Arrange and schedule internal and/or external meetings and teleconferences.
- Train and mentor PSS Assistants or peers in their day-to-day activities.
- Build and maintain good relationships across functional units.
- Ensure compliance with regulatory requirements and applicable study/project-specific plans.
- Assume responsibility for the quality of data processed and provide administrative support to PSS personnel.
- Perform all other duties as needed or assigned.
