Purpose
The Associate Director / Director, Global Intake and Triage Leader provides operational leadership for the end-to-end intake and triage processes for all Individual Case Safety Reports (ICSRs) across global Lilly and vendor operations. This role ensures timely, accurate, and compliant receipt, acknowledgment, and initial assessment of adverse event information from all sources globally. This role reports to the Sr. Director / Executive Director, Case Management Operations.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Collaborate with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.Operational Leadership - Intake and Triage
- Lead global operations for case intake from all sources including spontaneous reports, clinical trials, literature, digital/social media, regulatory authorities, business partners, and patients/consumers
- Oversee global triage processes ensuring accurate case classification, prioritization, and routing based on regulatory timelines and medical urgency
- Manage acknowledgment of receipt processes ensuring compliance with regulatory time frames (24-hour acknowledgment where required)
- Lead invalid case assessment and follow-up activities to obtain minimum criteria for valid ICSRs
- Oversee literature screening and case identification processes across all monitored publications
- Ensure appropriate issue pathways for serious, unexpected, or urgent safety issues
- Ensure regulatory compliance with FDA, EMA, ICH, and other health authority requirements for case receipt and initial processing
- Maintain oversight of intake performance metrics including receipt acknowledgment timeliness, triage accuracy, and intake quality scores
- Implement improvement initiatives to optimize intake efficiency and reduce processing time
- Support internal and external regulatory inspections and audits through direct involvement, resource coordination, document preparation, and subject matter expertise.
Cross-Functional Collaboration
- Partner with Medical Information, Affiliates, Medical Affairs, and Regulatory teams to ensure seamless case receipt workflows
- Collaborate with Case Processing and Reporting leaders to ensure smooth handoffs and clear communication
- Communicate with Technology teams to optimize case management system functionality for intake processes
- Support Product Quality/Complaint Management integration for combination product adverse events
- Collaborate with Case Management Commercial and Clinical Liaison to ensure seamless flow of information from various programs such as PSP, Market Research, etc.
People Management and Development
- Supervise multiple Manager-level leaders and their teams across global operations sites with dynamic prioritization based on volume and complexity.
- Translate departmental strategic plans into operational objectives and ensure team execution of adverse event collection standards across clinical trials and commercial programs.
- Monitor team performance, provide regular feedback, conduct performance evaluations, and identify development opportunities for direct reports.
- Foster a collaborative, inclusive team culture that promotes technical excellence, continuous learning, and cross-functional partnership.
- Ensure team compliance with relevant SOPs, global and local regulations, and training requirements.
Understand and Support of the EU QPPV role
- Understanding the roles and responsibilities of the EU Qualified Person.
- Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.
Minimum Qualification Requirements
- Bachelor's degree in nursing, pharmacy, life sciences, or related health sciences field
- 5 + years of experience in Pharmacovigilance, with at least 3 years focused on case intake/triage operations
- 2+ years managing people or leading teams
- Experience with safety databases (Argus, ARISg, Veeva or similar).
- Onsite Indianapolis IN, (3 days onsite / 2 remote)
Other Information/Additional Preferences
- Experience managing vendor relationships and outsourced operations
- Strong understanding of global pharmacovigilance regulations (FDA, EMA, ICH guidelines) and Good Pharmacovigilance Practices (GVP) and ICSR processing requirements
- Knowledge of literature monitoring and digital/social media surveillance
- Strong analytical skills with experience in metrics-driven operations
- Excellent communication skills in English (verbal and written)
- Ability to work effectively in a matrix, multicultural global environment
- Ability to travel when required
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