Role & Responsibilities
• Perform end-to-end ICSR case processing for marketed products in compliance with global regulations
• Assess seriousness, expectedness, causality, and ensure accurate global reporting
• Process literature ICSRs and maintain monitoring compliance
• Support aggregate reporting activities including PSURs and DSURs
• Maintain pharmacovigilance database integrity (LSMV experience preferred)
• Conduct reconciliation activities and support KPI/SLA tracking
• Collaborate with medical, clinical, and cross-functional teams on safety evaluations
• Identify safety trends and support signal detection and risk management
• Participate in regulatory audits and inspections
• Train and mentor junior pharmacovigilance associates
• Review SOPs and contribute to continuous PV process improvement
Qualification
• B.Pharm / M.Pharm / Pharm.D / BDS / B.Sc Nursing / M.Sc Nursing / BAMS / BHMS
Experience
• 4+ years of pharmacovigilance case processing experience
• Experience in Post-Marketing Surveillance (PMS)
• Strong knowledge of global pharmacovigilance regulations
• Hands-on experience with safety databases (LSMV preferred)
• Familiarity with SDEA concepts and SLA/KPI management
Skills
• Pharmacovigilance & Drug Safety Operations
• ICSR Processing (Marketed Products)
• Aggregate Reports (PSUR / DSUR)
• Global Safety Reporting
• Signal Detection (supporting role)
• Audit & Inspection Readiness
• Excellent analytical and communication skills
• Proficiency in Microsoft Office
Benefits
• Competitive salary & performance-based rewards
• Multiple annual leave entitlements
• Comprehensive health insurance for employee & family
• Retirement & long-term savings plans
• Global Employee Assistance Program (TELUS Health) – 24/7 support
• Life assurance coverage
• Flexible benefits (childcare support, gym discounts, travel subsidies, wellness programs)
• Inclusive, diverse, and harassment-free workplace
About The Company
• ICON Plc – A global leader in healthcare intelligence and clinical research, ICON provides comprehensive solutions across the clinical trial process. With a strong commitment to regulatory compliance and patient safety, ICON offers career advancement opportunities for professionals in pharmacovigilance and drug safety.
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