Director, Digitized Case Processing & Device Vigilance

As Director of Digitized Case Processing & Device Vigilance, you will architect the next generation of AI‑powered safety operations at a leading biopharma company, transforming complex global safety data into faster, smarter, and more compliant outcomes.

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 (HITL) oversight framework ensuring AI-assisted decisions meet global regulatory standards.
• Champion ICH E2B(R3) digital submission standards across all BMS reporting pathways.

Device Safety & MDR Compliance

• Own BMS's global Medical Device Reporting obligations (21 CFR Part 803), including timely 5-day and 30-day eMDR FDA submission...