Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree (preferred within health science or information technology)
• 2+ years of experience supporting drug development areas (e.g., Safety, Clinical, Project Management, Tech@Lilly, etc.).
• 2+ years of experience with data, reporting, and processes/systems.
• 2+ years implementing small and large systems/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.
• Demonstrates understanding of the PV safety system and business process.
• Demonstrates leadership in communicating effectively in written and verbal formats to various management levels.
• Demonstrates effective collaboration with teams spanning multiple geographies to develop and deliver applications.
• Strong leadership and project management skills.
• Demonstrates ability to be a self-starter comfortable with creating structure in an ambiguous environment; possesses a shown history of being a quick learner.
• Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties
• Demonstrates solid understanding and application of Computer System Quality (CSQ) requirements.
• Experience working in a highly regulated environment.

Nice To Haves

• Represent the organization’s analytics capabilities in various internal and external forums and conferences.
• Experience in operational and workflow analysis.
• Demonstrates experience with Artificial Intelligence (e.g. Machine Learning, Natural Language Processing, etc.)

Responsibilities

• 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.
• Maintain deep technical understanding of safety process knowledge in order 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 existing 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 applications.
• Employs applications and development efforts with PV organization and other regional centers to maintain alignment and foster consistency as appropriate across PV.
• Provides 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.
• Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
• Understand the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

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