Director, Digitized Case Processing & Device Vigilance

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...