Director, Digitized Case Processing & Digital Adverse Event Interfaces

About the role

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.

Responsibilities

• Drive initial process optimization and improvement following standard methodology
• Ensure resources are identified and aligned at the team-level to drive process optimization activities
• Lead optimization to align with the GVP document hierarchy
• Serve as the key point of contact for assigned processes
• Establish, track, and trend process metrics to achieve Quality Outcomes
• Lead Community of Practice with Local Process Owner (LPO), other Process Leads (PL), and Subject Matter Experts (SME)

Requirements

• 10+ years in Pharmacovigilance or Drug Safety, including at least 3–5 years at Director level
• A minimum of 7 years of hands-on experience in ICSR data acquisition, case intake, or processing in pharma, biotech, or CRO environments

Qualifications

• 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

Skills

• Strong leadership and project management skills
• Experience with AI, NLP, OCR, or RPA in a GxP-regulated environment
• Excellent communication and stakeholder management skills
• Ability to translate ambiguous future-state thinking into clear, actionable roadmaps

Benefits

Bristol Myers Squibb offers 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.