At a Glance
- Tasks: Lead AI-powered safety operations and transform global safety data into smarter outcomes.
- Company: Join a leading biopharma company at the forefront of innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Work in a dynamic, multicultural team across multiple countries.
- Why this job: Make a real impact in drug safety and compliance on a global scale.
- Qualifications: 10+ years in Pharmacovigilance with strong leadership and AI experience.
The predicted salary is between 100000 - 150000 £ per year.
As Director of Digitized Case Processing & Device Vigilance, you will architect the next generation of AI‑powered safety operations at a leading biopharma company, transforming complex global safety data into faster, smarter, and more compliant outcomes.
Responsibilities
- 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.
Qualifications
- 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 Experience
- 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).
Director, Digitized Case Processing & Device Vigilance employer: Bristol-Myers Squibb Company
At our leading biopharma company, we pride ourselves on fostering a dynamic and inclusive work environment that champions innovation and employee growth. As the Director of Digitized Case Processing & Device Vigilance, you will be at the forefront of transforming safety operations with cutting-edge AI technologies, while enjoying comprehensive benefits, a commitment to continuous improvement, and opportunities for professional development across our global teams in the US, UK, and India.
Contact Details:
Bristol-Myers Squibb Company Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Director, Digitized Case Processing & Device Vigilance
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We think you need these skills to ace Director, Digitized Case Processing & Device Vigilance
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Bristol-Myers Squibb Company!
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How to prepare for a job interview at Bristol-Myers Squibb Company
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Bristol-Myers Squibb Company that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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