Director, Digitized Case Processing & Device Vigilance
hace 1 día
Uxbridge
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. • 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., • 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). Demonstrated ability to lead and develop geographically dispersed, multicultural teams. Strong vendor and BPO management experience in outsourced case processing. • 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). Hybrid work model with at least 50% onsite at assigned facility. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. #J-18808-Ljbffr