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 EudraVigilance reporting under GVP Module VI.
• Define combination product dual‑reporting workflows across jurisdictions, partnering with Regulatory Affairs, Device Development, and Medical Affairs.
• Lead a high‑performing, multicultural team across the US, UK, and India within a matrix organisation spanning Japan and Switzerland.
• Drive cross‑functional governance with Safety, IT, Quality, Legal/Privacy, and Regulatory stakeholders.
• Represent Case Management in enterprise‑wide digital programs, system upgrades, and agency interactions.
• Ensure inspection‑ready compliance with ICH E2A/E2B(R3), GVP Modules VI & VII, 21 CFR Parts 314/600/803, EU MDR 2017/745, GDPR, HIPAA, and EMA.
• Build a KPI framework tracking ICSR cycle times, automation accuracy, ingestion rates, and MDR compliance.
• Embed a lean, right‑first‑time culture with root cause analysis and continuous improvement at its core.

Required Experience

• 10+ years in Pharmacovigilance or Drug Safety, with 3–5 years at Director level or equivalent.
• 7+ years of hands‑on ICSR case processing in pharma, biotech, or CRO settings.
• Proven track record deploying AI/NLP/RPA/ML solutions in a regulated GxP environment.
• Direct experience with MDR reporting (21 CFR Part 803), EU MDR/IVDR, and combination product workflows.
• Familiarity with Oracle Argus, Veeva Vault Safety, or ArisGlobal LifeSphere, and electronic submission platforms (FAERS, EudraVigilance, MHRA Yellow Card).
• Experience leading regulatory inspections (FDA, EMA, MHRA or equivalent).

Leadership

Demonstrated ability to lead and develop geographically dispersed, multicultural teams.

Vendor and BPO Management

Strong vendor and BPO management experience in outsourced case processing.

Education

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Engineering, Computer Science, or related field (required).
• Advanced degree (Master's, PharmD, MD, or PhD) (preferred).
• Qualifications in Digital Health, Data Science, AI/ML, or Health Informatics (highly desirable).

Location & Work Model

Hybrid work model with at least 50% onsite at assigned facility.

Equal Employment Opportunity Statement

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