Job Overview:
Senior case processing professional 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:
- Perform senior-level case processing across intake, triage, submission, data entry, and follow-up.
- Own quality control of processed cases and monitor quality standards.
- Carry out/review MedDRA coding and narrative writing to a high standard.
- Manage complex and escalated cases.
- Support aggregate report and signal activities as required.
- Mentor and support junior PV Scientists and associates.
- Ensure GVP compliance and quality across all activities.
- Support inspection readiness and audits for the case processing function.
Key Skills:
- End-to-end case processing
- ICSR QC ownership
- MedDRA coding
- Narrative writing
- Safety database knowledge - Argus, LSMV, Veeva or equivalent
- Training and mentoring
- GVP compliance
- Consumer health
