🌟 Career Opportunity: Pharmacovigilance Quality Reviewer (QC/Final Review)
If you’re an experienced Pharmacovigilance professional (3–4 years) with strong exposure to ICSR Quality Control and Final Review, this opportunity at TCS Pune could be your next big career move.
Given that you’re based in Pune, this is especially relevant for you — no relocation hassle, and strong growth potential in the PV domain.
💊 Role Overview: PV Quality Reviewer
In drug safety, accuracy is everything. As a Quality Reviewer, your role goes beyond processing — you become the final checkpoint before safety data reaches global regulators.
🔍 Key Responsibilities:
- ICSR Quality Check & Final Review
- Validate narratives, case completeness, and medical accuracy
- Ensure correct coding using MedDRA and WHODrug
- Regulatory Compliance
- Ensure submission compliance with:
- FDA (US)
- EMA (EU)
- MHRA (UK)
- Adhere to GVP guidelines and reporting timelines
- Ensure submission compliance with:
- Root Cause Analysis
- Identify recurring data trends and errors
- Provide structured feedback to case processors
- Database Proficiency
- Experience with safety systems like Argus or ArisG
📋 Eligibility Criteria
✔ 3–4 years of Pharmacovigilance experience
✔ Hands-on exposure in QC / Final Review
✔ Strong understanding of:
- Seriousness assessment
- Expectedness
- Causality
✔ Familiarity with the end-to-end PV lifecycle
✔ Comfort with medical terminology and regulatory documentation
📍 Work Location: Pune
Pune is one of India’s fastest-growing IT & healthcare hubs, offering:
- Strong professional network in Life Sciences
- Excellent work-life balance
- Growing pharmacovigilance ecosystem
💎 Why TCS?
Working at TCS means:
- 🌍 Global pharma client exposure
- 🤖 Exposure to AI & automation in PV workflows
- 📈 Clear career growth path (QC → Team Lead → Manager → SME)
- 🏆 Strong employer reputation and job stability
📩 How to Apply
📧 Send your updated CV to:
shivkumar.bhusse@tcs.com
📌 Subject Line Format:
Application for PV Quality Reviewer – [Your Name] – 4 Years Experience – Pune
🔎 Pro Tips:
- Clearly highlight ICSR Final Review experience
- Mention safety databases used (Argus/ArisG)
- Include measurable achievements (e.g., 99.5% quality score, audit readiness, etc.)
🌈 Final Thoughts
Pharmacovigilance is not just a job — it directly impacts patient safety worldwide. If you have the analytical eye and regulatory depth required for QC/Final Review, this is a strong opportunity in Pune’s PV landscape.
