Executive - Pharmacovigilance

Key Roles/Responsibilities

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2. End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines.
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4. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs.
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6. Enter and/ or submit cases to applicable regulatory authority safety databases.
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8. Perform and monitor literature for company molecules.
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10. Maintain and update safety logs and safety files.
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12. Prepare and share compliance data with QPPV.
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14. Provide data for compliance representation/monthly information system.
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16. Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
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18. Prepare for internal or external audits and inspections.
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20. Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.