Director, Digitized Case Processing & Device Vigilance

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: the Future of Pharmacovigilance at BMS

This isnt a maintenance role its a mandate to transform. As Director of Digitized Case Processing & Device Vigilance youll architect the next generation of AI-powered safety operations at one of the worlds 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 youll sit at the intersection of cutting-edge technology and patient safety driving real change that matters.

What Youll Own

AI & Digital Transformation

• Design and deliver BMSs 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 BMSs 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 35 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

• Bachelors degree in Life Sciences Pharmacy Medicine Nursing Biomedical Engineering Computer Science or related field(required)
• Advanced degree (Masters 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 doesnt 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 . Visit to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident Employer

A UK Government scheme

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R: Director Digitized Case Processing & Device Vigilance

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1