Senior Director – PV Case Management, ICSR

Eli Lilly and Company

full-time

Posted on: 8/31/2025

Origin: • 🇺🇸 United States

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💰 $151,500 - $222,200 per year

Senior

About the role

Provide technical leadership for the design, development, and implementation of Lilly’s end-to-end case management capabilities
Oversee ICSR activities and case quality, including data analysis, trend reporting, KPIs, and business insights
Manage ICSR vendor and CRO relationships, including process review and remediation
Define and monitor global ICSR metrics and safety business insights via dashboards
Drive digital enablement, operational excellence, and integration of new technologies for case management
Lead global projects on safety systems ensuring strategy, risk management, and continuous improvement
Prepare for and support regulatory inspections and internal/external audits related to ICSR processes
Build, mentor and maintain a community of ICSR subject matter experts and recruit/develop team
Represent Case Management cross-functionally and with external industry groups and partners
Support the EU QPPV role to enable fulfillment of legal responsibilities

Bachelor's degree in nursing, pharmacy, life sciences, health care or related field
8+ years of experience in the biotech or pharmaceutical industry
5+ years in ICSR, Case Management, PV Operations, or equivalent
Extensive knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, ICH)
Expertise in adverse event reporting, vendor and performance management
Experience with regulatory inspections
Proficiency with safety operation systems and tools (e.g., Safety database, MedDRA) preferred
Strong leadership, strategic thinking, and decision-making skills
Strong written, spoken and presentation communication skills
Leadership, negotiation, and influence skills
Continuous improvement and process optimization mindset
Ability to travel for business (15 – 25%)