Director, Digitized Case Processing & Digital Adverse Event Interfaces

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: 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 isnt just an operational goal. Its 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.

Thats the weight and the privilege of this role. And if that excites rather than intimidates you read on.

What are we actually looking for

Were looking for aDirector 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.

Youre probably already senior in your PV career. Youve led teams managed vendors survived inspections and built interfaces that actually work. But youre restless. Youve seen how much of PV case intake is still manual slow and fragile and youve been thinking about how to change it. Youve 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.

Heres what youll actually be doing

• Leading the AI-powered transformation of adverse event intakeYoull define and own BMSs 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. Youll have your name on a transformation that most PV professionals only read about in conference presentations.
• Owning the interfaces that connect BMSs safety ecosystemFrom Medical Information and Clinical Development teams to CROs licensing partners and regulatory portals like FAERS EudraVigilance MHRA and PMDA youll own every channel through which adverse event data flows in and out of BMS. Youll drive ICH E2B(R3) electronic exchange adoption and replace manual transmissions with validated auditable data pipelines.
• Reinventing how BMS screens medical literatureYoull lead the digital transformation of BMSs Medical Literature Screening programme moving to AI/NLP-driven screening across global databases including PubMed EMBASE Cochrane and J-Stage. Youll govern search string development manage AI classifier calibration and ensure the programme is always audit-ready.
• Building and leading a world-class global teamYoull lead a geographically distributed team across the US UK Switzerland India and Japan building a culture of psychological safety scientific rigour and continuous improvement. Youll define career pathways upskill your team in AI/ML fundamentals and develop the next generation of PV innovation leaders.
• Turning data into decisionsYoull design and own the KPI framework for your function touchless processing rates intake cycle times data completeness literature screening accuracy and vendor SLA performance. Youll use operational analytics and AI-generated dashboards to identify bottlenecks and continuously raise the bar.

What youll bring to the table

Youll need10 years in Pharmacovigilance or Drug Safety including at least 35 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. Youre equally at home in a regulatory conversation about ICH E2B(R3) compliance and a technical deep-dive on AI/NLP classifier performance. Youve been in the room during FDA EMA MHRA and PMDA inspections and you know what inspection-readiness really requires.

Ideally youll 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 safetyWed love to hear from you. Apply today and lets start a conversation.

#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.

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 employees 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

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