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10d ago Curated

Associate Director, Global Intake and Triage Leader

Eli Lilly
  • Other
  • Full-time
  • $123,000 – $180,400
  • 5+ years

Job description

Provides operational leadership for end-to-end intake and triage processes for Individual Case Safety Reports (ICSRs) across global Lilly and vendor operations. Ensures timely, accurate, and compliant receipt, acknowledgment, and initial assessment of adverse event information from all sources globally. Leads global operations for case intake from spontaneous reports, clinical trials, literature, digital/social media, regulatory authorities, business partners, and patients/consumers. Oversees global triage processes ensuring accurate case classification, prioritization, and routing based on regulatory timelines and medical urgency. Manages acknowledgment of receipt processes ensuring compliance with regulatory time frames. Leads invalid case assessment and follow-up activities. Oversees literature screening and case identification processes. Ensures appropriate escalation pathways for serious, unexpected, or urgent safety issues. Maintains oversight of intake performance metrics. Implements continuous improvement initiatives. Supports regulatory inspections and audits. Partners with cross-functional teams. Supervises multiple Manager-level leaders and their teams. Requires Bachelor's degree in nursing, pharmacy, life sciences, or related health sciences field; 5+ years in Pharmacovigilance with at least 3 years focused on case intake/triage operations; 2+ years managing people or leading teams; experience with safety databases.

Key responsibilities

  • Lead global operations for case intake from all sources
  • Oversee global triage processes for case classification and routing
  • Manage acknowledgment of receipt processes
  • Lead invalid case assessment and follow-up
  • Oversee literature screening and case identification
  • Ensure escalation pathways for serious safety issues
  • Maintain oversight of intake performance metrics
  • Implement continuous improvement initiatives
  • Support regulatory inspections and audits
  • Partner with cross-functional teams

What you bring

  • Bachelor's degree in nursing, pharmacy, life sciences, or related field
  • 5+ years Pharmacovigilance experience
  • 3+ years case intake/triage operations
  • 2+ years people management
  • Experience with safety databases (Argus, ARISg, Veeva or similar)
  • Strong understanding of global pharmacovigilance regulations
  • Excellent communication skills in English

Tags

PharmacovigilanceICSRCase IntakeTriageGlobal OperationsLeadership

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