Safety Science Coordinator I

7 days ago

Pune Maharashtra, India Fortrea Full time

**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.**:

- ** 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.**:
Learn more about our EEO & Accommodations request here.

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