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Assistant Ii, Pss

2 weeks ago

Pune, India Fortrea Full time

Data entry of safety data onto adverse event tracking systems
- Write patient narratives & 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 Labcorp 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

 Any other duties as assigned by the management.

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