Looking for a senior-level pharmacovigilance career in India? A Senior Specialist PV Regulatory Intelligence job in Mumbai is now open for experienced professionals with deep expertise in ICSR distribution, global PV regulations, and safety databases. This role is ideal for candidates aiming to work at the intersection of drug safety, regulatory intelligence, and global compliance systems.
🔍 Job Overview
- Job Title: Senior Specialist PV Regulatory Intelligence
- Location: Mumbai, India
- Department: Product Development – Established Pharma
- Experience Required: 10+ years in Pharmacovigilance
- Employment Type: Full-time
This pharmacovigilance regulatory intelligence job focuses on ensuring compliance in global ICSR distribution and maintaining high-quality safety database operations.
📌 Key Responsibilities
ICSR Distribution & Compliance
- Ensure compliance of global ICSR distribution via accurate rule setup in safety databases
- Perform plausibility checks and impact analysis for regulatory updates
- Implement updated distribution rules based on global PV requirements
Regulatory Intelligence & Monitoring
- Monitor regulatory information systems continuously
- Review distribution requirements from ASRs (Affiliate Safety Representatives)
- Act as SME for ICSR reporting requirements across PV functions
Database & System Management
- Maintain and update:
- Safety database contact mapping and distribution rules
- Product portfolio and CPD
- Distribution attribute and RuSH cards
- Monitor submission acknowledgements (success/failure)
Collaboration & Support
- Serve as contact point for:
- Case processing teams
- QPPV and compliance groups
- Safety database operations
- Support issue resolution related to ICSR distribution workflows
- Act as Deputy ICSR Distribution Coordinator
🎓 Qualifications & Skills
Education
- Master’s in Life Sciences / PhD / B.E. / B.Tech or equivalent
Experience
- Minimum 10 years in pharmacovigilance
- Strong expertise in:
- ICSR distribution processes
- Global pharmacovigilance regulations
- Drug safety databases and IT systems
Core Skills
- Excellent English communication (written & verbal)
- Advanced proficiency in Microsoft Office tools
- Experience in global safety database operations
- Strong attention to detail and analytical mindset
- Experience in training, audits, and compliance environments
💼 Salary & Benefits
- Estimated Salary Range: ₹18,00,000 – ₹30,00,000 per annum
- Exposure to global pharmacovigilance systems and EMA reporting
- Opportunity to work with cross-functional global teams
- Career growth in regulatory intelligence and drug safety leadership roles
🚀 Why This Role Matters
This Senior PV Regulatory Intelligence role is critical in ensuring global patient safety compliance. Professionals in this role directly impact how adverse event data (ICSRs) are distributed and reported to regulatory authorities worldwide.
With increasing regulatory scrutiny, expertise in ICSR distribution and pharmacovigilance compliance is among the most in-demand skills in the pharma industry.
📥 How to Apply
