Senior Executive – Pharmacovigilance

About the role

The Senior Executive – Pharmacovigilance will lead end‑to‑end safety activities for Piramal Critical Care’s portfolio. You will manage individual case safety reports, monitor literature, and support regulatory submissions while ensuring compliance with global pharmacovigilance standards.

Key responsibilities

• Handle complete case management: receipt, follow‑up, database entry, peer review and timely submission to regulatory authorities.
• Manage ICSR mailboxes, track incoming reports and perform reconciliation of cases.
• Enter and submit cases to applicable safety databases and download cases from authority portals.
• Conduct continuous literature screening for company molecules and maintain safety logs.
• Prepare and share compliance data with the Qualified Person for Pharmacovigilance (QPPV) and generate aggregate safety reports such as PADER, PSUR and PBRER.
• Assist in product complaint handling, audit support and response to regulatory queries.

Required profile

• Bachelor’s or Master’s degree in Pharmacy.
• 2‑3 years of experience in pharmacovigilance, including at least 1 year of ICSR processing and literature screening.
• Experience authoring aggregate safety reports (PADER, PBRER, PSUR).
• Strong attention to detail and ability to work under regulatory timelines.

Required skills

• ICSR processing
• Literature screening
• Aggregate safety report authoring (PADER, PBRER, PSUR)
• Regulatory database submission
• Case management