Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation

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 processes. They will use their business process analysis, benchmarking, and analytic trends knowledge to influence and drive the PV technology and analytics strategy forward. Primary Responsibilities Strategic and Technical Leadership Proactively assess and advise PV business on key upcoming and emerging trends based on internal data and external environmental changes. Research new technologies and work with business, corporate analytics, and IT teams to build and deploy applications and analytics models. Influence and drive PV technology strategy through external and internal benchmarking, business process automation needs, and analytic trends. Lead strategic cross‑functional projects across PV and PV Partners for automation, technology, and analytics needs. Maintain deep technical understanding of safety process knowledge to apply technology and automation to PV processes. System Development & Maintenance Lead analytics and automation solutions to address large cross‑functional issues for PV and associated business partners. Develop use cases, translate business issues into user stories, and map them into a technology solution. Oversee the development and maintenance of new and existing PV systems, tools, technologies, and strategies supporting related business processes (e.g., timeline updates, project status reports, risk management). Drive business readiness activities for technology implementations. Act as PV system owner or custodian, strategically influencing and driving the system change management process as needed. Partner with Quality to ensure that standard validation principles and system development methodologies are used to build and maintain PV-based applications. Align PV organization and other regional centers to maintain consistency across PV. Operational Excellence Consult and partner with PV leadership and Quality to deliver on regulatory and audit requests. Lead engagement to define, deliver, and report measures that assess the health of PV systems. Oversee the definition and implementation of tools and applications that provide insight into PV operations. Compliance Deep knowledge of existing regulations, guidelines, and trends for PV automation and technology (e.g., e2B, eDC, AI, safety mailings) to proactively maintain compliance. Ensure the confidentiality of company information is protected. Provide subject‑matter expertise for inspections and audits related to safety systems. Maintain a confidentiality agreement before disclosing company information to outside parties. Understand the roles of the EU Qualified Person and support the QP’s legal responsibilities. Minimum Qualification Requirements Bachelor’s degree (preferred in health science or information technology). At least 2 years of experience supporting drug development areas such as Safety, Clinical, Project Management, or View email address on click.appcast.io. At least 2 years of experience with data, reporting, and processes or systems. At least 2 years of experience implementing small and large systems or technology projects. Experience in the pharmaceutical industry and/or PV or clinical research. Qualified applicants must be authorized to work in the United States on a full‑time basis; Lilly does not sponsor work authorization or visas. Other Information / Additional Preferences Understanding of the PV safety system and business processes. Strong communication skills in written and verbal formats for various management levels. Collaborative ability across multiple geographies to deliver applications. Strong leadership and project‑management skills. Experience representing the organization’s analytics capabilities in internal and external forums and conferences. Operational and workflow analysis experience. Self‑starter in ambiguous environments; quick learner. Experience with Artificial Intelligence (e.g., Machine Learning, Natural Language Processing). Understanding and application of Computer System Quality requirements. Experience in a highly regulated environment. Some travel may be required. Position based in Indianapolis, IN; relocation assistance provided. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $115,500 - $169,400. Full‑time employees may also be eligible for a company bonus and a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation, medical, dental, vision, prescription drug benefits, flexible spending accounts, life insurance, death benefits, time‑off, and well‑being resources. Lilly is a proud EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. #J-18808-Ljbffr BioSpace