These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.
Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial
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 & code adverse events accurately using MedDRA (for Marketed products, if applicable)
Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
Assist in generation of queries and 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
Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc), and prioritise the reports for processing and submission within the regulatory and/or study specific applicable timelines
Assist in the reconciliation of databases, as applicable
Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc as appropriate
Assist in the maintenance of supporting files/ documentation regarding adverse event reporting requirements in all countries, if applicable
Support upload/archival of case/study/project documentation, as appropriate
Build and maintain good PSS relationships across functional units
Support compliance of operations with governing regulatory requirements
Any other duties as assigned by management
* The above job duties are completed by the staff as applicable, depending on the role they are assigned to.
- Locations: Pune India
- Type: Full time
- Job requisition ID: 2363082