At a Glance
- Tasks: Lead AI-driven case processing and device vigilance to transform global safety operations.
- Company: Join Bristol Myers Squibb, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, comprehensive health benefits, and opportunities for professional growth.
- Other info: Work in a dynamic, multicultural environment with a focus on continuous improvement.
- Why this job: Shape the future of pharmacovigilance and make a real impact on patient safety.
- Qualifications: 10+ years in Pharmacovigilance with strong leadership and AI experience.
The predicted salary is between 100000 - 150000 £ per year.
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)
Director, Digitized Case Processing & Device Vigilance in Denham employer: Bristol Myers Squibb
Bristol-Myers Squibb in Uxbridge is an exceptional employer, offering a dynamic work culture that prioritises collaboration and innovation. Employees benefit from extensive career growth opportunities, mentorship programs, and the chance to contribute meaningfully to life-changing clinical trials, all while enjoying a supportive environment that values data integrity and compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Digitized Case Processing & Device Vigilance in Denham
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Bristol Myers Squibb. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Bristol Myers Squibb.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Bristol Myers Squibb. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Bristol Myers Squibb is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director, Digitized Case Processing & Device Vigilance in Denham
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!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Bristol Myers Squibb that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Bristol Myers Squibb!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Bristol Myers Squibb, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Bristol Myers Squibb
✨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 that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Bristol Myers Squibb’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
