Executive - Pharmacovigilance

Key Roles / Responsibilities

• 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.
• Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs.
• Enter and / or submit cases to applicable regulatory authority safety databases.
• Perform and monitor literature for company molecules.
• Maintain and update safety logs and safety files.
• Prepare and share compliance data with QPPV.
• Provide data for compliance representation / monthly information system.
• Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
• Prepare for internal or external audits and inspections.
• Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.

Skills Required

Case Management