Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
$115,500 - $169,400 USD yearly
Operations
The purpose of the Associate Director PV Systems Strategy and Implementation is to develop, implement, and maintain streamlined and compliant PV systems that enable PV organization objectives.
Primary Responsibilities
- Proactively assess and advise PV on emerging trends.
- Research new technologies and build/deploy applications and analytics models with business, analytics, and IT teams.
- Influence PV technology strategy using benchmarking, automation needs, and analytic trends.
- Lead cross-functional projects for automation, technology, and analytics.
- Apply safety process knowledge to PV technology/automation.
System Development & Maintenance
- Lead analytics and automation solutions for cross-functional issues.
- Develop use cases; translate business issues into user stories and technology solutions.
- Oversee development/maintenance of PV systems and tools (e.g., timeline updates, status reports, risk management).
- Drive business readiness for technology implementations.
- Maintain PV systems as system owner/custodian and influence change management.
- Partner with Quality to use validation principles and system development methodologies.
- Align PV applications across regional centers.
Operational Excellence
- Partner with PV leadership/Quality for regulatory and audit requests.
- Define, deliver, and report measures to understand system health.
- Oversee tools/applications providing operational insight.
Compliance
- Apply knowledge of regulations/guidelines and trends to maintain compliance.
- Support inspections/audits for safety systems.
- Ensure confidentiality agreements are executed before disclosing information.
- Support EU Qualified Person (QP) legal responsibilities.
Minimum Qualifications
- Bachelor’s degree (preferred in health science or IT).
- 2+ years supporting drug development (Safety, Clinical, Project Management, Tech@Lilly, etc.).
- 2+ years with data/reporting and processes/systems.
- 2+ years implementing small and large systems/technology projects.
- Experience in pharma and/or PV or clinical research.
- Authorized to work in the U.S. full-time; visa sponsorship not provided.
Preferred Skills/Experience
- PV safety system and business process understanding.
- Strong written/verbal communication across management levels.
- Collaboration across geographies; leadership and project management.
- Represent analytics capabilities in forums/conferences.
- Operational/workflow analysis; self-starter in ambiguity.
- AI experience; CSQ requirements; highly regulated environment experience.
- Some travel; based in Indianapolis, IN (relocation provided).
Primary Responsibilities
- Proactively assess and advise PV on emerging trends.
- Research new technologies and build/deploy applications and analytics models with business, analytics, and IT teams.
- Influence PV technology strategy using benchmarking, automation needs, and analytic trends.
- Lead cross-functional projects for automation, technology, and analytics.
- Apply safety process knowledge to PV technology/automation.
System Development & Maintenance
- Lead analytics and automation solutions for cross-functional issues.
- Develop use cases; translate business issues into user stories and technology solutions.
- Oversee development/maintenance of PV systems and tools (e.g., timeline updates, status reports, risk management).
- Drive business readiness for technology implementations.
- Maintain PV systems as system owner/custodian and influence change management.
- Partner with Quality to use validation principles and system development methodologies.
- Align PV applications across regional centers.
Operational Excellence
- Partner with PV leadership/Quality for regulatory and audit requests.
- Define, deliver, and report measures to understand system health.
- Oversee tools/applications providing operational insight.
Compliance
- Apply knowledge of regulations/guidelines and trends to maintain compliance.
- Support inspections/audits for safety systems.
- Ensure confidentiality agreements are executed before disclosing information.
- Support EU Qualified Person (QP) legal responsibilities.
Minimum Qualifications
- Bachelor’s degree (preferred in health science or IT).
- 2+ years supporting drug development (Safety, Clinical, Project Management, Tech@Lilly, etc.).
- 2+ years with data/reporting and processes/systems.
- 2+ years implementing small and large systems/technology projects.
- Experience in pharma and/or PV or clinical research.
- Authorized to work in the U.S. full-time; visa sponsorship not provided.
Preferred Skills/Experience
- PV safety system and business process understanding.
- Strong written/verbal communication across management levels.
- Collaboration across geographies; leadership and project management.
- Represent analytics capabilities in forums/conferences.
- Operational/workflow analysis; self-starter in ambiguity.
- AI experience; CSQ requirements; highly regulated environment experience.
- Some travel; based in Indianapolis, IN (relocation provided).