Associate Director - Senior Case Manager

Job Position Overview

The Associate Director, Senior Case Manager, Case Management Operations is 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. The role settles the hardest case-level questions and keeps case execution consistent across Lilly and vendor sites. It is a working-level authority that Case Management Operations leadership and process SMEs rely on for case decisions.

Responsibilities

ICSR Intake, Processing and Submissions

• 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. Help create and deliver shared learnings, as needed.
• Serve as the escalation point for complex E2B acknowledgment rejections and submission failures that sites cannot resolve and decide the root cause and correction approach at the case level.
• Advise Case Management Operations leadership on the case-level drivers behind backlog, throughput or timeliness trends, and highlight concerns to strategic vendor management team with recommendations of operational response.
• Support the calibration of ICSR quality reviewers so that the same quality error is scored the same way at every site.
• Escalate systemic quality or compliance risks to the Case Management leadership team, as applicable.

Escalation Support and Working-Level Guidance

• Be the escalation point for process SMEs and Case Management Operations managers on case decisions they cannot resolve.
• Review Shared Learnings content prepared by product SMEs and case managers for accuracy and consistency before release.
• Represent the case processor's view of the safety database and intake tools in user testing, defect triage and change requests, as needed.
• Identify manual, repetitive steps in case processing (for example repeated lookups or manually written narratives) and document the requirements for tooling or automation.

Cross-Functional Partnering

• Work with Clinical and Commercial Liaisons on intake channels and product-specific case handling conventions.
• Give operational input to Standards & Compliance when procedures that affect case processing are revised.
• Partner with internal and external stakeholders on process and system updates, as needed.
• Perform other related duties, as assigned
• Provide case-level information requested by the EU QPPV office, such as case status and submission evidence.

Basic Qualifications

• Bachelor’s degree
• Minimum 5 years of hands-on ICSR processing experience covering intake, data entry and submission, including at least 2 years reviewing or quality-checking the work of other processors.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Preferences

• Experience coaching and calibrating case processors across more than one site or vendor.
• Applied knowledge of ICSR reporting requirements (for example ICH E2B(R3), ICH E2D, EU GVP Module VI, FDA 21 CFR 314.80 and 600.80) at the level of individual case decisions.
• Hands-on proficiency with a safety database (for example Argus or Veeva Vault Safety) and with MedDRA and WHO Drug coding.
• Track record of resolving complex validity, duplicate and coding questions and explaining the rationale clearly to processors.
• Working proficiency in Excel for case volume and quality tracking (for example pivot tables and lookups).
• Previous experience in/ with an outsourced or multi-vendor case processing model.
• Prior work with case processing capacity and throughput analysis.
• Previous experience in/ with handling device, combination product or clinical trial serious adverse event (SAE) cases, including SAE reconciliation.
• Pior work with intake or case processing automation tools.
• Proven ability to deliver case processing work through a site transition or product routing change.

Additional Information

Location: US: Indianapolis, Indiana. Travel Percentage (%): 0-10%. Language Requirements: Fluent written and spoken English, with the ability to write clear case guidance for multinational teams.