Director, Digitized Case Processing & Device Vigilance
As Director of Digitized Case Processing & Device Vigilance, you’ll architect the next generation of AI‑powered safety operations at one of the world’s leading biopharma companies, turning complex global safety data into faster, smarter and more compliant outcomes. Leading a globally distributed team across the US, UK, and India, you’ll sit at the intersection of cutting‑edge technology and patient safety — driving real change that matters.
What You’ll Own
AI & Digital Transformation
- 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
What You Bring
- 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
- 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)
Equal Employment Opportunity Statement
Bristol Myers Squibb is Disability Confident – Employer. BMS is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable accommodation prior to accepting a job offer. For assistance, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our full Equal Employment Opportunity statement.
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