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 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 is essential, along with upholding documentation quality and compli
📌 Senior Pharmacovigilance Associate (Chennai)
🏢 ICON
📍 Chennai
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