Associate Director, Global Intake and Triage Leader
Eli Lilly and Company
August 24, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Purpose
The Associate Director / Director, Global Intake and Triage Leader provides operational leadership for end-to-end intake and triage of all Individual Case Safety Reports (ICSRs) across global Lilly and vendor operations.
Primary Responsibilities
- Lead global case intake from spontaneous reports, clinical trials, literature, digital/social media, regulatory authorities, business partners, and patients/consumers.
- Oversee triage (classification, prioritization, routing) and ensure timely receipt acknowledgment (24-hour where required).
- Assess invalid cases to obtain minimum criteria for valid ICSRs.
- Oversee literature screening/case identification and ensure proper pathways for serious/unexpected/urgent safety issues.
- Ensure regulatory compliance (FDA, EMA, ICH, and other health authorities) and monitor intake performance metrics.
- Implement process improvement to optimize efficiency and reduce processing time.
- Support regulatory inspections/audits via coordination, documentation, and subject matter expertise.
Collaboration
- Partner cross-functionally with Medical Information, Medical Affairs, Regulatory, Case Processing/Reporting, Technology, Product Quality/Complaint Management, and Commercial/Clinical Liaison.
- Supervise and develop multiple manager-level leaders across global sites.
- Support EU Qualified Person (QPPV) responsibilities.
Minimum Qualifications
- Bachelor’s degree in nursing, pharmacy, life sciences, or related health sciences.
- 5+ years pharmacovigilance; 3+ years case intake/triage operations.
- 2+ years people management.
- Safety database experience (Argus, ARISg, Veeva, or similar).
- Indianapolis, IN (3 days onsite / 2 remote).
Additional Preferences/Skills
- Vendor/outsourced operations experience.
- Knowledge of global PV regulations and GVP/ICSR processing requirements.
- Literature monitoring and digital/social media surveillance knowledge.
- Analytical, metrics-driven, strong English communication; matrix/global environment; ability to travel.
Compensation/Benefits (as stated)
- Anticipated wage: $123,000–$180,400; bonus eligibility; comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off, well-being benefits.
Application Instructions
- If you need an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
The Associate Director / Director, Global Intake and Triage Leader provides operational leadership for end-to-end intake and triage of all Individual Case Safety Reports (ICSRs) across global Lilly and vendor operations.
Primary Responsibilities
- Lead global case intake from spontaneous reports, clinical trials, literature, digital/social media, regulatory authorities, business partners, and patients/consumers.
- Oversee triage (classification, prioritization, routing) and ensure timely receipt acknowledgment (24-hour where required).
- Assess invalid cases to obtain minimum criteria for valid ICSRs.
- Oversee literature screening/case identification and ensure proper pathways for serious/unexpected/urgent safety issues.
- Ensure regulatory compliance (FDA, EMA, ICH, and other health authorities) and monitor intake performance metrics.
- Implement process improvement to optimize efficiency and reduce processing time.
- Support regulatory inspections/audits via coordination, documentation, and subject matter expertise.
Collaboration
- Partner cross-functionally with Medical Information, Medical Affairs, Regulatory, Case Processing/Reporting, Technology, Product Quality/Complaint Management, and Commercial/Clinical Liaison.
- Supervise and develop multiple manager-level leaders across global sites.
- Support EU Qualified Person (QPPV) responsibilities.
Minimum Qualifications
- Bachelor’s degree in nursing, pharmacy, life sciences, or related health sciences.
- 5+ years pharmacovigilance; 3+ years case intake/triage operations.
- 2+ years people management.
- Safety database experience (Argus, ARISg, Veeva, or similar).
- Indianapolis, IN (3 days onsite / 2 remote).
Additional Preferences/Skills
- Vendor/outsourced operations experience.
- Knowledge of global PV regulations and GVP/ICSR processing requirements.
- Literature monitoring and digital/social media surveillance knowledge.
- Analytical, metrics-driven, strong English communication; matrix/global environment; ability to travel.
Compensation/Benefits (as stated)
- Anticipated wage: $123,000–$180,400; bonus eligibility; comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off, well-being benefits.
Application Instructions
- If you need an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.