About the Role
About the Role
We are looking for a motivated PV Operations professional with hands-on experience in case processing and pharmacovigilance operational activities. This role supports global safety operations by ensuring accurate, compliant, and timely handling of Individual Case Safety Reports (ICSRs) and related documentation.
Key Responsibilities
Perform ICSR case processing in compliance with global regulatory requirements (ICH, GVP, FDA, EMA).
Support SDEA (Signal Detection & Evaluation Activities) documentation and case analysis.
Assist in Safety Database (SDB) optimization, reconciliation, and quality checks.
Contribute to SOP review, updates, and compliance activities.
Ensure adherence to internal quality standards and timelines.
Support audits, inspections, and safety data queries as required.
Requirements
3–5 years of experience in Pharmacovigilance / Safety Operations.
Strong working knowledge of ICSR workflows and safety databases.
Familiarity with SOPs, SDEA, and regulatory guidelines.
Life Sciences / Pharmacy / Medical background preferred.
Good communication skills and attention to detail.