Director, Digitized Case Processing & Device Vigilance

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Shape the Future of Pharmacovigilance at BMS This isn't a maintenance role — it's a mandate to transform. 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 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) #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated 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 workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Bristol Myers Squibb is Disability Confident – Employer A UK Government scheme Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1603482 : Director, Digitized Case Processing & Device Vigilance