Senior Pharmacovigilance Associate (Hands-on experience in handling Clinical Trial & PMS cases)
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.
Looking for candidates who are currently based in Chennai. Immediate joiners are preferred.
As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.
What You Will Be Doing:
We are looking for an experienced professionals who has 4+ years of case processing experience in Post Marketing Surveillance.
Experience in ICSR processing for marketed products.
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.
This role involves leading efforts to collect, evaluate, and process adverse event reports, making sure all reporting is accurate and submitted on time according to regulatory and company standards.
You will analyze safety data carefully, interpret findings, and identify trends or potential safety issues that need further investigation.
Responsibilities also include preparing and submitting detailed periodic safety update reports (PSURs) and other regulatory documents while adhering to international compliance requirements.
You'll work closely with medical and clinical teams to determine the clinical importance of reported adverse events and support risk management initiatives.
Maintaining and ensuring the integrity of pharmacovigilance databases i
📌 Senior Pharmacovigilance Associate (Chennai)
🏢 ICON
📍 Chennai