Senior Executive

Job Description

Job description

Travel: No

Reporting Structure

Reports to Manager

Essential Qualification

Bachelors/ Masters degree in Pharmacy

• - Overall 2-3 years of experience in Pharmacovigilance with at least 1 year of relevant work experience in ICSR processing,
• - Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc.
• 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 handling of product complaints and reconciliation.
• - 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.
• - Preparation/Drafting of aggregate reports (PADER and PSURs).
• - Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.