- Preparing internal & external reports in response to adverse event information received by the Drug Safety and Pharmacovigilance Department
Assist in ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.)
- Review adverse event information received for completeness and consistency, initiate case follow-up activities/AE query management, and independently generate narratives in accordance with department processes.
- Perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database.
- Follow defined norms and Processes for case management and closure activities, Adhere to SOP of the company for communication and Documentations.
- Ensure compliance with corporate and departmental standard operating procedures
- Communicates product safety issues to team members in a timely manner.
- Contributes to presentations, discussions, and data summaries on safety issues at meetings with external and internal partners.
- Participate in audits and inspections as SME for global case processing.
- Ensure Deviations and CAPAs are followed up on and closed in due time
- Perform other activities as directed by Drug Safety and Pharmacovigilance management.
Experience: 3-5 Yrs