Are you an experienced pharmacovigilance professional looking to advance your career in post-marketing case processing? A leading global CRO, ICON plc, is hiring a Pharmacovigilance Associate in Chennai, India. This is a strong opportunity for candidates with 2+ years of PV experience in ICSR processing, MedDRA coding, and drug safety compliance.
This role focuses on post-marketing surveillance, ensuring patient safety through accurate adverse event reporting, case triage, and regulatory complianceโmaking it ideal for professionals aiming to grow in global pharmacovigilance operations.
Key Responsibilities โ Pharmacovigilance Associate
- Perform adverse event case processing from intake to closure
- Manage safety inbox and acknowledge receipt of cases
- Conduct case triage and book-in to safety databases
- Write clinical narratives and ensure data accuracy
- Code events, drugs, and medical history using MedDRA and WHO-DD
- Assess seriousness, causality, and expectedness
- Apply product labeling and perform quality checks (QC)
- Generate follow-ups and manage query resolution
- Process literature ICSRs and maintain compliance
- Support aggregate reporting (PSUR/DSUR)
- Collaborate with cross-functional teams on safety issues
- Ensure adherence to global pharmacovigilance regulations and SOPs
Eligibility Criteria & Qualifications
Educational Requirements
- B.Pharm / M.Pharm / Pharm.D
- BDS / BSc Nursing / MSc Nursing
- BAMS / BHMS
Experience Required
- Minimum 2+ years in pharmacovigilance case processing
- Strong experience in post-marketing surveillance (PMS)
- Hands-on expertise in ICSR handling and safety databases
Core Skills
- Proficiency in MedDRA coding and WHO-DD
- Knowledge of SDEA, KPI/SLA metrics
- Understanding of PV regulations and reporting timelines
- Strong analytical and communication skills
- Experience in reconciliation and aggregate reporting
Salary & Benefits
- Estimated Salary: โน4.5 LPA โ โน8 LPA (based on experience)
- Health insurance for employees and family
- Life insurance coverage
- Paid annual leave and work-life balance benefits
- Employee Assistance Program (24/7 support)
- Retirement and savings plans
- Flexible benefits (gym, travel, childcare support)
Why Choose ICON for Pharmacovigilance Careers?
ICON plc is a globally recognized clinical research organization (CRO) known for excellence in drug safety, clinical trials, and regulatory services. Working at ICON provides exposure to global PV systems, international compliance standards, and career progression in pharmacovigilance and drug safety domains.
How to Apply
