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ICON plc, a global leader in healthcare intelligence and clinical research, is hiring a Senior Pharmacovigilance Associate for its Chennai, India location. This is a full-time role with Office with Flex working options, ideal for experienced pharmacovigilance professionals specializing in post-marketing surveillance (PMS) and LSMV safety databases.
This opportunity is well-suited for candidates with strong expertise in ICSR processing, global safety reporting, PSUR/DSUR preparation, and regulatory compliance, looking to advance their career with a reputed global CRO.
🔍 Key Responsibilities – Senior Pharmacovigilance Associate
- 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
🎓 Eligibility & Qualifications
Education (Any One):
- B.Pharm / M.Pharm
- Pharm.D
- BDS
- B.Sc Nursing / M.Sc Nursing
- BAMS / BHMS
Experience:
- 4+ years of pharmacovigilance case processing experience
- Mandatory 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
💼 Required 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 at ICON
ICON offers a competitive and employee-centric benefits package, including:
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- 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
📍 Job Location
Chennai, Tamil Nadu, India
(Office with Flex – Hybrid Work Model)
📝 How to Apply
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