Roles & Responsibilities
• Perform end-to-end ICSR case processing for marketed products as per global regulations.
• Assess seriousness, expectedness and causality and ensure timely global reporting.
• Process literature ICSRs and maintain compliance with monitoring requirements.
• Support aggregate reporting activities including PSURs and DSURs.
• Maintain safety database integrity with hands-on experience in LSMV preferred.
• Perform reconciliation activities and support KPI and SLA tracking.
• Collaborate with medical, clinical and cross-functional teams on safety evaluations.
• Support signal detection, risk management activities and identification of safety trends.
• Participate in regulatory audits and inspections.
• Train and mentor junior pharmacovigilance associates.
• Review SOPs and contribute to continuous process improvement.
Qualification
• B.Pharm / M.Pharm, Pharm.D, BDS, B.Sc Nursing / M.Sc Nursing, BAMS / BHMS
Experience
• Minimum 4+ years of pharmacovigilance case processing experience.
• Mandatory experience in Post-Marketing Surveillance (PMS).
Skills
• Strong knowledge of global pharmacovigilance regulations.
• Hands-on experience with safety databases (LSMV preferred).
• Expertise in ICSR processing for marketed products.
• Experience with PSUR / DSUR and aggregate reports.
• Familiarity with SDEA concepts and SLA / KPI management.
• Audit and inspection readiness.
• Excellent analytical, communication and documentation skills.
• Proficiency in Microsoft Office tools.
About the Company
ICON plc is a global healthcare intelligence and clinical research organization delivering outsourced development and commercialization services to the pharmaceutical, biotechnology and medical device industries, supporting innovation and patient safety across the product lifecycle worldwide.
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