Executive - Pharmacovigilance

Reporting Structure Reports to Manager 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. Essential Qualification Bachelors/ Masters degree in Pharmacy Competencies Good communication and interpersonal skills, both written and verbal Ability to manage multiple concurrent tasks Proven ability to meet strict deadlines Ability to work independently and in a team environment Competent in use of desktop applications: Microsoft word, excel and PowerPoint