Director, Digitized Case Processing & Device Vigilance
We are looking for an experienced Director to lead AI‑driven case processing and device vigilance at Bristol Myers Squibb. This role will architect the next generation of safety operations, turning complex global safety data into faster, smarter and more compliant outcomes.
Shape the Future of Pharmacovigilance at BMS
This isn’t a maintenance role — it’s a mandate to transform. As Director, you will lead a globally distributed team across the US, UK, and India, sit at the intersection of cutting‑edge technology and patient safety, and drive real change that matters.
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 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
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
- 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)
EEO & Equality
Bristol Myers Squibb is Disability Confident – Employer. BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
BMS will never request payments, financial information, or social security numbers during our application or recruitment process. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
We encourage applicants with disabilities to request reasonable workplace accommodations or adjustments before accepting a job offer. For support, contact adastaffingsupport@bms.com or visit careers.bms.com/eeo-accessibility for the full Equal Employment Opportunity statement.
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