Job Description

Summary Of Responsibilities Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Hands on experience working on clinical trial cases, spontaneous cases, Post marketing solicitate(PMS) and good to have LAM. Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection and follow-up. Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines. Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform Database reconciliation with Data Management team or sponsor/client as needed. Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), 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. Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate. Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed. Begin participating in signal detection and trend and pattern recognition activities, as appropriate. Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided. Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting. Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency. Participate in Fortrea project team and client meetings, as appropriate. Prepare and support coordination of safety study files for archiving at completion of projects. Contribute to root cause analysis, including the CAPA plan development and implementation. Support Audits and/or inspections preparation. Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees. All other duties as needed or assigned. Learn more about our EEO & Accommodations request here. Show more Show less