Ernst & Young (EY) is actively hiring experienced professionals for the role of Senior Consultant โ Pharmacovigilance Case Processing in Bengaluru. This opportunity is ideal for candidates with strong expertise in drug safety, ICSR processing, and global pharmacovigilance compliance.
If you have 4โ8 years of experience in pharmacovigilance case processing, Argus/Veeva Safety systems, and regulatory compliance, this role offers strong career growth in a global consulting environment.
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Job Overview
- Role: Senior Consultant โ Pharmacovigilance (PV Case Processing)
- Location: Bengaluru, India
- Experience: 4โ8 Years
- Industry: Pharmacovigilance / Drug Safety / Regulatory Compliance
- Employment Type: Full-Time
- Salary: โน10โ18 LPA (Estimated Competitive Range)
Key Responsibilities
Pharmacovigilance Case Processing
- Handle end-to-end ICSR processing from intake to submission
- Perform case triage, data entry, and medical coding
- Assess seriousness, expectedness, and causality
- Ensure timely SAE reporting as per global timelines
Regulatory Compliance
- Maintain compliance with FDA, EMA, ICH guidelines (E2E, GVP)
- Support audit readiness and regulatory inspections
- Ensure accurate expedited reporting of adverse events
Database & Systems Handling
- Work on PV systems like Argus Safety, Veeva Vault, ArisGlobal
- Perform quality checks and reconciliation activities
- Support validation and implementation of safety systems
Collaboration & Leadership
- Coordinate with medical reviewers and safety physicians
- Guide and mentor junior PV professionals
- Participate in process improvement initiatives
Required Qualifications
- Bachelorโs or Masterโs degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences / Biotechnology / Nursing
- Experience:
- 4โ8 years in pharmacovigilance case processing
- Hands-on experience with ICSR handling and SAE reporting
- Technical Skills:
- Strong knowledge of PV lifecycle and compliance frameworks
- Experience with Argus, Veeva, ArisG systems
- Understanding of GVP, GCP, and global regulations
- Additional Skills:
- Analytical thinking & problem-solving
- Strong communication and stakeholder management
- Experience with Power BI dashboards (preferred)
Preferred (Good-to-Have) Skills
- Literature screening experience (Japanese market preferred)
- Signal detection & risk management knowledge
- Clinical trial safety reporting exposure
- PV certifications (DIA, RAPS)
- Computer System Validation (CSV) for GxP systems
Benefits of Working at EY
- Global exposure in drug safety and regulatory consulting
- Career growth in a multi-disciplinary global team
- Training, mentorship, and structured development plans
- Opportunity to work with top pharmaceutical clients worldwide
- Flexible work environment and performance-driven culture
Why This Role is Important
This role directly contributes to patient safety and global drug monitoring systems by ensuring that adverse events are properly assessed, documented, and reported in compliance with international standards.
How to Apply
