Director, Digitized Case Processing & Device Vigilance
Uxbridge, England, United Kingdom • Posted June 30, 2026
Job Type:
Full-time
Location:
Uxbridge, England
Posted:
June 30, 2026
Category:
other-general
Application Deadline:
August 09, 2026
Role Description
Director, Digitized Case Processing & Device Vigilance (R1603482)
Lead the transformation of BMS’s case processing and device vigilance through AI-driven solutions, overseeing global teams and ensuring compliance across multiple regulatory frameworks.
Responsibilities
- Design and deliver BMS's multi-year roadmap for intelligent ICSR case processing using AI, NLP, RPA, OCR, and LLMs.
- Deploy and validate next-generation platforms (ArisGlobal LifeSphere, IQVIA Vigilance Detect, Oracle Argus AI workflows) in a fully GxP‑compliant environment.
- Govern a human‑in‑the‑loop oversight framework ensuring AI‑assisted decisions meet global regulatory standards.
- Champion ICH E2B(R3) digital submission standards across all BMS reporting pathways.
- Own BMS's global Medical Device Reporting obligations (21 CFR Part 803), including timely 5‑day and 30‑day eMDR FDA submissions.
- Lead EU MDR/IVDR device vigilance integration and Eudra...
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