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 current 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 recent 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 (India)
🏢 IRE
📍 India