ICON Hiring Pharmacovigilance Associate – Clinical Trial Case Processing Role
ICON plc is hiring Pharmacovigilance Associate for professionals experienced in Clinical Trial Case Processing and Post Marketing Surveillance.
This opportunity is ideal for candidates from B.Pharm, M.Pharm, Pharm.D, Nursing, BAMS, BHMS, and Life Sciences backgrounds looking to build careers in Pharmacovigilance, ICSR Processing, Drug Safety Operations, MedDRA Coding, and Global Clinical Safety.
📋 Job Overview
| Details | Information |
|---|---|
| Job Role | Pharmacovigilance Associate |
| Company | ICON plc |
| Location | Chennai, India |
| Department | Drug Safety & Pharmacovigilance |
| Qualification | B.Pharm / M.Pharm / Pharm.D / BDS / Nursing / BAMS / BHMS |
| Experience Required | Minimum 2 Years in PV Case Processing |
| Mandatory Skill | Clinical Trial Case Processing & Post Marketing Surveillance |
| Work Model | Hybrid |
📌 Key Responsibilities
- Collect, assess, and process adverse event reports
- Perform case triage and safety database book-in activities
- Enter case details and write case narratives accurately
- Code events, drugs, and medical history using MedDRA & WHO-DD
- Apply correct product labeling and perform QC checks
- Finalize case processing and generate follow-up queries
- Handle safety inbox management and case acknowledgment
- Support reconciliation and aggregate reporting activities
- Process literature ICSRs and maintain compliance
- Support SOP reviews and mentor new joiners
- Maintain knowledge of global PV regulations and guidelines
- Support patient safety and compliance activities
🎓 Eligibility Criteria
- B.Pharm / M.Pharm / Pharm.D
- BDS / Nursing / MSc Nursing
- BAMS / BHMS / Life Sciences
- Minimum 2 years experience in PV Case Processing
- Experience in Post Marketing Surveillance case processing mandatory
- Knowledge of MedDRA & WHO-DD coding
- Understanding of seriousness, causality, and expectedness
- Strong analytical and communication skills
- Attention to detail and compliance mindset
⭐ Preferred Skills
- ICSR Processing
- Clinical Trial Case Processing
- Post Marketing Surveillance
- Aggregate Reporting (PSUR/DSUR)
- Drug Safety Operations
- Global PV Compliance
🌍 Why Join ICON?
- Opportunity to work with a global CRO leader
- Exposure to international Drug Safety projects
- Strong career growth in Pharmacovigilance
- Hybrid work flexibility and employee well-being support
- Learning opportunities in global safety regulations
- Professional growth through diverse healthcare projects
📄 Resume Tips
- Highlight PV case processing and PMS experience clearly
- Mention MedDRA, WHO-DD, and ICSR processing exposure
- Add aggregate reporting or reconciliation experience if available
- Use ATS-friendly resume formatting
- Showcase analytical and documentation skills
- Mention global safety database experience clearly
- Keep resume concise and achievement-focused
🎯 Interview Tips for Pharmacovigilance Associate Role
- Prepare ICSR workflow and case processing concepts thoroughly
- Revise seriousness, causality, and expectedness concepts
- Understand MedDRA coding and narrative writing basics
- Prepare examples related to PMS case handling
- Revise PSUR, DSUR, and reconciliation concepts
- Be ready to explain safety database experience
- Practice compliance and quality-related interview questions
- Research ICON plc and global CRO operations before interview
❓ Frequently Asked Questions (FAQs)
1. Is Post Marketing Surveillance experience mandatory?
Yes, candidates must have solid experience in Post Marketing Surveillance case processing.
2. What is the minimum experience required?
Candidates should have a minimum of 2 years experience in Pharmacovigilance case processing.
3. What coding dictionaries are required?
Knowledge of MedDRA and WHO-DD coding is important for this role.
4. Is this a hybrid role?
Yes, the role follows a hybrid work model.
5. What qualification backgrounds are eligible?
B.Pharm, M.Pharm, Pharm.D, Nursing, BAMS, BHMS, and related healthcare backgrounds are eligible.
🧩 Fun Learning & Career Growth
Improve your Pharmacovigilance and Drug Safety knowledge with quizzes and learning resources.
🚀 Job Application Link
Please make sure to read the complete job description carefully before submitting your application. Make sure your Pharmacovigilance experience and case processing knowledge align with the role requirements.
