- Indianapolis, Indiana, United States
- On-site
- Full-time · Director
- $117K–$172K per year
- 5+ years
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
- Nice to have: ICH E2B(R3)