Associate Director - Pharmacovigilance (PV) Systems Strategy and Implementation

Primary 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.
• System Development & Maintenance
• 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.
• Operational Excellence
• Provides consultation and partners with PV leadership and Quality to deliver upon regulatory and audit requests.
• Led 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.
• Compliance
• 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.
• Ensures that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
• Represents the organization’s analytics capabilities in various internal and external forums and conferences.

Minimum Qualification 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.

Other Information/Additional Preferences

• 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.
• Represents the organization’s analytics capabilities in various internal and external forums and conferences.
• Experience in operational and workflow analysis.
• 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 experience with Artificial Intelligence (e.g. Machine Learning, Natural Language Processing, etc.).
• Demonstrates solid understanding and application of Computer System Quality (CSQ) requirements.
• Experience working in a highly regulated environment.