Associate Director - Pharmacovigilance; PV Systems Strategy and Implementation

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The purpose of the Associate Director PV Systems Strategy and Implementation is to develop, implement, and maintain streamlined and compliant systems that enable the PV organization’s objectives. This role will work with stakeholders to analyze workflows and business processes to identify improvement opportunities, efficiency enhancements, and increased quality of data and process. They will use their business process analysis, benchmarking, and analytic‑trends knowledge to influence and drive the PV technology and analytics strategy forward.

• Proactively assesses and advises PV business on key upcoming/emerging trends (based on assessment of internal data/trends and external environmental changes).
• Research new technologies and work with business, corporate analytics, and IT teams in building and deploying applications/analytics models.
• Influences and drives PV technology strategy through external/internal benchmarking, business process automation needs, and analytic trends.
• Leads strategic cross‑functional projects across PV and PV Partners for automation, technology and analytics needs.
• Maintains deep technical understanding of safety process knowledge in order to apply technology and automation to PV processes.

• Lead analytics and automation solutions to address large cross‑functional issues for PV and associated business partners.
• Provides experience developing use cases, translates business issues into user stories and subsequent mapping into a technology solution.
• Responsible for the oversight and/or development of new and existingฟ PV systems, tools, technologies and strategies in support of related business processes (i.e. timeline updates, project status reports, risk management, etc).
• Drive business readiness activities for technology implementations.
• Accountable for maintenance of PV systems as system owner or custodian while strategically influencing and driving the system change‑management process as needed.
• Partners with Quality to ensure that standard validation principles and system development methodologies are used to build and maintain PV‑based fisi applications.
• Employs applications and development efforts with PV organization and other regional centers to maintain alignment and foster consistency as appropriate across PV.

• Occupies consultation and partners with PV leadership and Quality to deliver upon regulatory and audit requests.
• Leads engagement to define, deliver, and report measures to understand the health of our systems.
• Works across PV to provide oversight to the definition and implementation of tools and applications that provide insight into operations.

• Deep knowledge of existing regulations/guidelines and trends for PV automation and technology (i.e. e2b, eDC, AI, safety mailings) to proactively motivate change to maintain compliance.
• Understands the confidential nature of company information and takes vital steps to ensure its protection.
• Provides subject‑matter expertise for inspections and audits in relation to safety systems.
• Secrets ensures an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
• Understands the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities.

• Bachelor’s degree (preferred within health science or information technology)
• 2+ years of experience supporting drug development areas (e.g., Safety, Clinical, Project Management,…