Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation

Role Summary

The Associate Director PV Systems Strategy and Implementation develops, implements, and maintains streamlined and compliant PV systems to support the PV organization’s objectives. The role analyzes workflows and business processes with stakeholders to identify opportunities for improvement, efficiency enhancements, and higher data and process quality. It leverages business process analysis, benchmarking, and analytic trends to influence and drive PV technology and analytics strategy. Location: Indianapolis, IN.

Responsibilities

• Strategic and Technical Leadership: Advise PV on emerging trends, research new technologies, and collaborate with business, analytics, and IT teams to deploy applications/analytics models; drive PV technology strategy through benchmarking and automation needs; lead cross-functional projects for automation, technology, and analytics; maintain deep technical understanding of safety processes to apply technology and automation.
• System Development & Maintenance: Lead analytics and automation solutions for cross-functional PV issues; develop use cases and translate business issues into technology solutions; oversee and develop PV systems, tools, technologies, and strategies; drive business readiness for technology implementations; act as system owner/custodian and guide change management; ensure standard validation principles and development methodologies with Quality; align with regional centers to maintain consistency.
• Operational Excellence: Consult with PV leadership and Quality to meet regulatory/audit requests; define, deliver, and report measures of system health; oversee tools and applications that provide operational insights.
• Compliance: Maintain knowledge of PV automation/regulatory trends; protect confidential information; provide SMEs for inspections/audits; ensure confidentiality agreements when disclosing information; support EU QP responsibilities.

Qualifications

• Required: Bachelor’s degree (preferred in health science or information technology)
• Required: 2+ years supporting drug development areas (e.g., Safety, Clinical, Project Management, Tech@Lilly, etc.)
• Required: 2+ years of experience with data, reporting, and processes/systems
• Required: 2+ years implementing small and large systems/technology projects
• Required: Demonstrates understanding of the PV safety system and business process
• Required: Experience in the pharmaceutical industry and/or PV or clinical research
• Preferred: Demonstrates leadership in communicating effectively to various management levels
• Preferred: Demonstrates effective collaboration across geographies to develop and deliver applications
• Preferred: Strong leadership and project management skills
• Preferred: Ability to represent analytics capabilities in internal and external forums
• Preferred: Experience in operational and workflow analysis
• Preferred: Self-starter with ability to create structure in ambiguous environments; quick learner
• Preferred: Experience with Artificial Intelligence (e.g., Machine Learning, NLP) and CSQ requirements
• Preferred: Experience in a highly regulated environment
• Preferred: Some travel may be required
• Preferred: Relocation provided for Indianapolis, IN base

Education

• Bachelor’s degree (preferred within health science or information technology)

Skills

• Leadership and strategic thinking
• Project management and cross-functional collaboration
• Analytical thinking, data governance, and workflow analysis
• Communication (written and verbal) across multiple management levels
• Knowledge of PV systems, automation, and regulatory considerations
• Experience with AI/ML and NLP capabilities

Additional Requirements

• Some travel may be required
• Based in Indianapolis, IN; relocation may be provided