ICON plc is hiring a Pharmacovigilance Associate for Post-Marketing Surveillance case processing in Chennai. This full-time Office with Flex role is a great opportunity for professionals with 2+ years of PV experience seeking pharma jobs and pharmacovigilance careers in India.
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About the Company
ICON plc is a world-leading healthcare intelligence and clinical research organization (CRO). The company delivers innovative solutions across clinical development, pharmacovigilance, and real-world evidence to help bring safe and effective therapies to patients faster.
ICON fosters an inclusive, high-performance culture and is committed to patient safety, regulatory compliance, and operational excellence. It offers excellent pharmaceutical careers in India with global exposure and strong focus on employee well-being.
Job Details
- Company Name: ICON plc
- Experience: Minimum 2 years in safety case processing (Post-Marketing Surveillance preferred)
- Qualification: B.Pharm, M.Pharm, Pharm.D, BDS, B.Sc Nursing, M.Sc Nursing, BAMS, BHMS
- Location: Chennai, Tamil Nadu, India
- Work Type: Full-time, Office with Flex
Job Description
ICON is seeking a Pharmacovigilance Associate to handle post-marketing adverse event case processing. The role involves collecting, assessing, processing, and reporting safety data while ensuring compliance with global regulatory requirements and internal standards.
Pharmacovigilance Associate (Post-Marketing Case Processing)
- Department: Pharmacovigilance / Drug Safety
- Market: Clinical Research Organization (CRO)
- Role: Pharmacovigilance Associate
- Experience: 2+ years in Post-Marketing PV case processing
- Education/Qualification: B.Pharm / M.Pharm / Pharm.D / BDS / Nursing (B.Sc/M.Sc) / BAMS / BHMS
Skills/Qualifications
- Minimum 2 years of hands-on experience in Post-Marketing Surveillance case processing
- Strong knowledge of seriousness, expectedness, causality assessment, and global reporting rules
- Proficiency in MedDRA and WHO-DD coding
- Experience in case triage, data entry, narrative writing, and QC checks
- Familiarity with safety inbox management, follow-up queries, and literature ICSRs
- Understanding of reconciliation processes, aggregate reporting (PSUR/DSUR), SDEA, and KPI/SLA
- Excellent analytical skills, attention to detail, and communication abilities
- Ability to mentor new joiners and review SOPs
Key Responsibilities
- Collect, assess, and process adverse event reports for post-marketing cases
- Manage safety inbox, perform triage, and book-in cases into the safety database
- Enter case details accurately and write medically coherent narratives
- Code events, drugs, and medical history using MedDRA/WHO-DD
- Apply product labeling, perform quality checks, and finalize cases
- Generate follow-up queries and ensure timely regulatory compliance
- Support literature ICSR processing and maintain monitoring requirements
- Collaborate with cross-functional teams on safety-related queries
- Stay updated with global pharmacovigilance regulations and guidelines
- Mentor new team members and contribute to SOP reviews
Benefits/Perks
- Competitive salary with performance-based incentives
- Flexible work arrangements (Office with Flex)
- Comprehensive health insurance and wellness benefits
- Global Employee Assistance Programme (TELUS Health)
- Retirement planning support and life assurance
- Annual leave entitlements and country-specific optional benefits
- Strong focus on inclusion, belonging, and work-life balance
- Opportunities for career growth in global pharmacovigilance
How to Apply
Apply directly through the official ICON Careers portal using Job Requisition ID JR139660.
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Apply now and take the next step in your drug safety career with ICON plc!
Why You Should Join
ICON offers a dynamic and inclusive environment where your contributions directly impact patient safety and regulatory compliance. With a global presence and commitment to innovation, the company provides excellent learning opportunities, mentorship, and long-term career growth in pharmacovigilance within the clinical research industry.
FAQs
What is the minimum experience required for the Pharmacovigilance Associate role at ICON?
Minimum 2 years of experience in safety case processing, with solid hands-on experience in Post-Marketing Surveillance.
What qualifications are accepted for this pharma job in Chennai?
B.Pharm, M.Pharm, Pharm.D, BDS, B.Sc/M.Sc Nursing, BAMS, or BHMS.
Is this a fully remote or hybrid position?
It is an Office with Flex role based in Chennai.
What key skills are most important for this PV position?
Strong Post-Marketing case processing experience, MedDRA coding, narrative writing, and regulatory knowledge are essential.
