Associate Director - Senior Case Manager

Lilly • Indianapolis, IN

2d • $117,000 - $171,600

About The Position

The Associate Director, Senior Case Manager, Case Management Operations is the senior hands-on practitioner for Individual Case Safety Report (ICSR) work across intake, case processing, and regulatory submission. This role resolves the most difficult case-level questions and promotes consistent case execution across Lilly and vendor sites. It serves as a working-level authority for Case Management Operations leadership and process subject-matter experts.

The role provides operational decisions and escalation support for complex ICSR validity, case classification, duplicate and linked-case, quality, and submission issues. It also supports audits and inspections, coaching and shared learning, quality-review calibration, process and system improvements, and collaboration with internal and external partners. The position is located in Indianapolis, Indiana, with 0–10% travel. Fluent written and spoken English is required.

Requirements

• Bachelor’s degree.
• At least 5 years of hands-on ICSR processing experience covering intake, data entry, and submission.
• At least 2 years reviewing or quality-checking the work of other processors.
• Authorization to work in the United States on a full-time basis; Lilly will not support or sponsor work authorization or visas for this role.
• Fluent written and spoken English, with the ability to write clear case guidance for multinational teams.

Nice To Haves

• Experience coaching and calibrating case processors across more than one site or vendor.
• Applied knowledge of ICSR reporting requirements, such as 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 such as Argus or Veeva Vault Safety, and with MedDRA and WHO Drug coding.
• Track record resolving complex validity, duplicate, and coding questions and clearly explaining the rationale to processors.
• Working proficiency in Excel for case volume and quality tracking, such as pivot tables and lookups.
• Experience with an outsourced or multi-vendor case-processing model.
• Experience with case-processing capacity and throughput analysis.
• Experience handling device, combination-product, or clinical-trial serious adverse event cases, including SAE reconciliation.
• Experience with intake or case-processing automation tools.
• Ability to deliver case-processing work through a site transition or product-routing change.

Responsibilities

• Make operational decisions on complex ICSR validity questions, including minimum criteria, unidentifiable reporters or patients, counterfeit and product-quality reports, reports without a suspect Lilly product, and case versus non-case determinations.
• Monitor operational metrics and trends, resolve or escalate emerging risks and concerns, and address issues identified through quality review or leadership.
• Resolve complex, duplicate, and linked-case scenarios and confirm the correct master case.
• Support case management operations audits and inspections with case-level evidence and case walk-throughs; conduct root-cause investigations and implement CAPAs.
• Coach case managers and vendor trainers on difficult case scenarios and help create and deliver shared learnings.
• Resolve complex E2B acknowledgment rejections and submission failures, determine case-level root causes, and decide correction approaches.
• Advise leadership on case-level drivers of backlog, throughput, and timeliness trends; raise concerns and recommend operational responses to strategic vendor management.
• Support calibration of ICSR quality reviewers to promote consistent scoring across sites.
• Escalate systemic quality or compliance risks to the Case Management leadership team.
• Serve as an escalation point for process SMEs and Case Management Operations managers on unresolved case decisions.
• Review Shared Learnings prepared by product SMEs and case managers for accuracy and consistency.
• Represent case processors’ needs concerning the safety database and intake tools in user testing, defect triage, and change requests.
• Identify repetitive manual case-processing steps and document requirements for tooling or automation.
• Work with Clinical and Commercial Liaisons on intake channels and product-specific case-handling conventions.
• Provide operational input to Standards & Compliance when procedures affecting case processing are revised.
• Partner with internal and external stakeholders on process and system updates.
• Provide case-level information requested by the EU QPPV office, including case status and submission evidence.
• Perform other related duties as assigned.

Benefits

• Company bonus eligibility for full-time equivalent employees, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior