Job Description:
- Preparing internal & external reports in response to adverse event information received by the Drug Safety and Pharmacovigilance Department
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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.
Qualification: B.Pharma/M.Pharma
Experience: 3-5 Yrs
Salary: Negotiable
Contact Details:
hr@mitoconbiopharma.com
