Job Overview:

Senior case processing qualified providing high-quality end-to-end ICSR processing, Quality Review and Case Submission across the full case lifecycle within a large-volume OTC/consumer healthcare pharmacovigilance program. Supports and mentors junior team members.

Experience:

2+ years of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains

Key Responsibilities:

1. Perform senior-level case processing across intake, triage, submission, data entry, and follow-up.
2. Own quality control of processed cases and monitor quality standards.
3. Carry out/review MedDRA coding and narrative writing to a high standard.
4. Manage complex and escalated cases.
5. Support aggregate report and signal activities as required.
6. Mentor and support junior PV Scientists and associates.
7.



Ensure GVP compliance and quality across all activities.
8. Support inspection readiness and audits for the case processing function.

Key Skills:

1. End-to-end case processing
2. ICSR QC ownership
3. MedDRA coding
4. Narrative writing
5. Safety database knowledge - Argus, LSMV, Veeva or equivalent
6. Training and mentoring
7. GVP compliance
8. Consumer health

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr PV Scientist - Case Processing (Mumbai)
🏢 Soterius Life Sciences
📍 Mumbai