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.

Primary Responsibilities:

Strategic and Technical Leadership

• 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.
• 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.

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.
• Understand the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities.

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, View email address on us.fitly.work, 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. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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.
• Represent 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.
• Some travel may be required
• This position is based in Indianapolis, IN and relocation is provided

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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