Location– Pune
Summary of Responsibilities:
- 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 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).
- 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.
