Director, Digitized Adverse Event Processing – Device Vigilance

Bristol Myers Squibb

Director responsible for the strategy and implementation of digitized case processing workflows at BMS. Leading a global team to enhance pharmacovigilance through digital transformation.

Posted 7/13/2026full-timePrinceton • New Jersey • 🇺🇸 United StatesLead💰 $217,520 - $263,577 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in digitized case processing and device vigilance, leveraging AI, NLP, and RPA to enhance pharmacovigilance workflows while ensuring compliance with GxP and global regulatory standards. Proven leadership in managing diverse teams and driving digital transformation in a regulated environment.

Highest-signal resume keywords

PharmacovigilanceDigital TransformationAI/NLP/RPA SolutionsDevice Safety ReportingGlobal Safety Database Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceICSR Case ProcessingAI SolutionsNLP SolutionsRPA SolutionsGxP ComplianceMDR ReportingData ScienceHealth InformaticsDigital Health

Soft Skills

LeadershipTeam ManagementCross-Cultural CommunicationStrategic ThinkingVendor Management

Tools & Technologies

Oracle ArgusVeeva Vault SafetyArisGlobal LifeSphereFAERSEudraVigilanceMHRA Yellow Card

Certifications & Qualifications

Bachelor's Degree in Life SciencesMaster's DegreePharmDMDPhD

Industry Keywords

Drug SafetyRegulatory AffairsGxP StandardsCombination Product ReportingICH E2B(R3) Standards

Tech Stack

Tools & technologies

OracleRPAVault

About the role

Key responsibilities & impact

The Director, Digitized Case Processing & Device Vigilance is a senior leadership role accountable for the end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows within BMS's global PV Operations & Systems function.
This role leads the transformation of ICSR and Medical Device Report Safety processing through artificial intelligence (AI), natural language processing (NLP), robotic process automation (RPA), and digital ingestion platforms while ensuring full compliance with applicable GxP standards and global device reporting (MDR) regulatory requirements.
The Director will oversee a globally distributed team spanning the US, UK, and India within a matrix environment also including Japan, and will serve as the key interface between the Case Management function PS sub-functions and IT/Digital, Regulatory Affairs, Quality, and external vendors.
The role holder is accountable for driving BMS toward a proactive, data-led pharmacovigilance model in alignment with applicable global regulatory frameworks, while ensuring that device and combination product safety processing and reporting obligations are fulfilled.

Requirements

What you’ll need

Minimum Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Engineering, Computer Science, or a related Healthcare or Life Sciences field
Advanced degree (Master's, PharmD, MD, or PhD) in a relevant discipline is preferred
Additional qualifications in Digital Health, Data Science, AI/ML, or Health Informatics are highly desirable
Minimum 10+ years of experience in Pharmacovigilance, Drug Safety, or a closely related field, with at least 3–5 years at Director or equivalent senior leadership level
Minimum 7 years of hands-on ICSR case processing experience within a pharmaceutical, biotech, or CRO environment
Demonstrated expertise in digital transformation of PV processes, including deployment of AI, NLP, OCR, RPA, or ML solutions within a regulated GxP environment
Proven experience with device safety reporting obligations including MDR (21 CFR Part 803), EU MDR/IVDR, and combination product dual-reporting workflows
Experience with global safety database systems (e.g., Oracle Argus, Veeva Vault Safety, ArisGlobal LifeSphere) and electronic submission platforms (FAERS, EudraVigilance, MHRA Yellow Card)
Working knowledge of ICH E2B(R3) electronic submission standards and associated data elements
Prior experience managing geographically distributed, multicultural teams across multiple time zones (US, UK, and India exposure preferred)
Experience managing regulatory inspections (FDA, EMA, MHRA, or equivalent) related to case management or PV systems
Track record of vendor and CRO management in the context of outsourced case processing operations
Prior engagement with AI governance frameworks or digital health regulatory policy is an advantage.

Benefits

Comp & perks

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.