Director, Digitized Case Processing & Device Vigilance in Denham

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 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.

Global Leadership & Governance

• 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.

Quality, Compliance & Continuous Improvement

• 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 AI pharmacovigilance strategy.
• 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.

Qualifications

• 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 Experience

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