Director, Digitized Case Processing & Digital Adverse Event Interfaces

Job description

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. The purpose of this role is to ensure consistent global leadership for key R&D Quality processes within WWPS. This role focuses on all aspects of individual case safety reporting (ICSR) processes. The Process Lead (PL) is accountable to drive initial process optimization and improvement following standard methodology, ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the GVP document hierarchy. This will include serving as the key point of contact for assigned processes. The PL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens. The PL will establish, track, and trend process metrics to achieve Quality Outcomes and will lead Community of Practice with Local Process Owner (LPO), other Process Leads (PL), and Subject Matter Experts (SME). The PL role reports into the Global Process Owner (GPO) who is accountable to provide high-level oversight and decision making in optimizing and ongoing sustaining of the process. The GPO will serve as executive oversight and primary decision-maker for assigned processes. The GPO will provide decisions required and oversight to Process Leads (PL), endorse metrics to achieve Quality Outcomes, and support Community of Practice. What if your next role actually mattered - not just to your career, but to patients around the world? At Bristol Myers Squibb, we believe that getting patient safety information right - faster, smarter, and more reliably, isn't just an operational goal. It's a moral one. Every adverse event we capture more accurately, every process we automate with precision, every AI model we govern responsibly: it all traces back to a real person whose safety depends on us getting it right. That's the weight and the privilege of this role. And if that excites rather than intimidates you, read on. What are we actually looking for? We're looking for a Director of Digitized Case Processing & Digital Adverse Event Interfaces - a leader who sits comfortably at the crossroads of pharmacovigilance science, cutting-edge technology, global regulation, and people leadership. You're probably already senior in your PV career. You've led teams, managed vendors, survived inspections, and built interfaces that actually work. But you're restless. You've seen how much of PV case intake is still manual, slow, and fragile and you've been thinking about how to change it. You've got opinions about AI in GxP environments, about touchless processing, and about how literature screening should be done in 2026 and beyond. This is the role where those opinions become strategy and that strategy becomes reality. Here's what you'll actually be doing Leading the AI-powered transformation of adverse event intake You'll define and own BMS's multi-year digital intake roadmap, deploying AI/NLP, OCR, RPA, LLMs, and Agentic AI to build genuinely automated, touchless AE case creation workflows, all within a validated GxP framework. You'll have your name on a transformation that most PV professionals only read about in conference presentations. Owning the interfaces that connect BMS's safety ecosystem From Medical Information and Clinical Development teams to CROs, licensing partners, and regulatory portals like FAERS, EudraVigilance, MHRA, and PMDA, you'll own every channel through which adverse event data flows in and out of BMS. You'll drive ICH E2B(R3) electronic exchange adoption and replace manual transmissions with validated, auditable data pipelines. Reinventing how BMS screens medical literature You'll lead the digital transformation of BMS's Medical Literature Screening programme moving to AI/NLP-driven screening across global databases including PubMed, EMBASE, Cochrane, and J-Stage. You'll govern search string development, manage AI classifier calibration, and ensure the programme is always audit-ready. Building and leading a world-class global team You'll lead a geographically distributed team across the US, UK, Switzerland, India, and Japan, building a culture of psychological safety, scientific rigour, and continuous improvement. You'll define career pathways, upskill your team in AI/ML fundamentals, and develop the next generation of PV innovation leaders. Turning data into decisions You'll design and own the KPI framework for your function, touchless processing rates, intake cycle times, data completeness, literature screening accuracy, and vendor SLA performance. You'll use operational analytics and AI-generated dashboards to identify bottlenecks and continuously raise the bar. What you'll bring to the table You'll need 10+ years in Pharmacovigilance or Drug Safety, including at least 3–5 years at Director level, and a minimum of 7 years of hands-on experience in ICSR data acquisition, case intake, or processing in pharma, biotech, or CRO environments. What truly sets you apart is your ability to take a digital transformation vision and make it real — translating ambiguous future-state thinking into clear, actionable roadmaps that get delivered. You're equally at home in a regulatory conversation about ICH E2B(R3) compliance and a technical deep-dive on AI/NLP classifier performance. You've been in the room during FDA, EMA, MHRA, and PMDA inspections — and you know what inspection-readiness really requires. Ideally, you'll also bring: Experience deploying AI, NLP, OCR, or RPA in a GxP-regulated environment A proven track record building AE data interfaces with internal and external partners Literature screening programme management, including AI-assisted platforms Deep knowledge of ICH E2B(R3) across at least two major ICH regions Familiarity with ARIS Global LifeSphere, Oracle Argus, or Veeva Vault Safety Experience managing cross-regional teams and exposure to AI governance in life sciences Ready to shape the future of patient safety? We'd love to hear from you. Apply today and let's start a conversation. #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. Compensation Overview: Madison - Giralda - NJ - US: $217,520 - $263,577 Princeton - NJ - US: $217,520 - $263,577 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the