Summary of Responsibilities:

• Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to:
• Maintenance of adverse event tracking systems.
• Set-up and maintenance of project files, and central files for documentation.
• Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines.
• Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox.
• Assist with processing of the adverse events, including but not limited to:
• Data entry of safety data onto adverse event tracking systems.
• Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
• Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
• Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed.
• Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
• Maintenance of adverse event tracking systems
• Assist with peer/quality review of processed reports and support with trends and actions as needed.
• Assist in the reconciliation of databases, as applicable.
• Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
• Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate.
• Prepare and support coordination of safety study files for archiving at completion of projects.
• Arrange and schedule internal and/or external meetings/teleconferences.
• Train and mentor, the PSS Assistants or peers in their day-to-day activities.
• Build and maintain good PSS relationships across functional units.
• Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans.
• Assume responsibility for quality of data processed. Provide administrative support to PSS personnel.
• All other duties as needed or assigned.

Physical Demands/ Work Environment:

• Office Environment or remote.

How to Apply?

Interested candidates can apply through Fortrea’s official career portal or relevant job platforms. Don’t miss this chance to work with a global leader in clinical research and safety science!

APPLY HERE