Pharmacovigilance Associate (Hands-on experience in Clinical Trial & Post Marketing case processing)
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Pharmacovigilance Associate at ICON, you will monitor and ensure the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information.
What You Will Be Doing:
- Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements
- Partner with cross-functional teams to address safety-related questions and support ongoing investigations
- Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards
- Manage safety inbox and acknowledge case receipt.
- Perform case triage and book-in to safety database.
- Enter case details accurately and write narratives.
- Code events, drugs, and medical history using MedDRA/WHO-DD.
- Apply correct product labeling and perform QC checks.
- Finalize case processing and generate queries for follow-up
- Knowledge of seriousness, expectedness, causality, and global reporting
- Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR)
- Ability to mentor new joiners and review SOPs
- Working knowledge of SDEA and KPI/SLA basics
- Process literature ICSRs and maintain compliance with monitoring requirements
Must Have Criteria:
- Minimum 2 years of experience in safety background, with direct involvement in case processing
- Solid experience in Post Marketing Surveillance/Clinical Trial case processing
- Bachelors degree in life sciences
- Robust analytical skills with attention to detail in data collection and reporting
- Excellent communication and
📌 Pharmacovigilance Associate (Chennai)
🏢 IRE
📍 Chennai