The senior hands-on practitioner for Individual Case Safety Report (ICSR) work across the three operational pillars of Case Management Operations: intake, case processing and regulatory submission.
Compensation
The anticipated wage for this position is $117,000 - $171,600
Responsibilities
Act as the key operational decisionmaker on complex ICSR validity questions, including the four minimum criteria, unidentifiable reporters or patients, counterfeit and product-quality reports, and reports with no suspect Lilly product, as well as case versus non-case determinations.
Monitor operational metrics and trends to identify emerging risks, and ensure timely resolution or escalation of concerns, including those identified through quality review or raised by leadership.
Resolve difficult, complex, duplicate and linked-case scenarios (for example parent–child and pregnancy cases, or the same patient reported through several sources) and confirm the correct master case.
Provide audit and inspection support for case management operations, including case-level evidence and case walk-throughs when requested, including performing the root cause investigations and CAPA implementations.
Coach case managers and vendor trainers on difficult case scenarios.
Requirements
Bachelor’s degree
Nice to have: coaching and calibrating case processors
Associate Director - Senior Case ManagerLilly · Indianapolis, US