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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.

Job Responsibilities

Technology Development & Maintenance

+ Support and/or develop new or existing systems, tools, and technologies for PV.

+ Perform verification activities for PV technologies and reports as required.

+ Provide User Acceptance Testing support for all the business system needs.

+ Support the system change management process for PV systems.

+ Perform configuration of PV safety systems such as global reporting rules and conducting Product License Study (PLS) activities.

PV Data Reporting & Compliance

+ Provide PV and Lilly safety reports through existing/adhoc queries with high quality and accuracy through appropriate review and validation.

+ Prepare and maintain records to provide information for summaries, charts, graphs, and monthly or ad-hoc reports.

+ Provide standard or custom validated reports for use in audits and inspections.

+ Maintains awareness of existing regulations/guidelines to ensure alignment of deliverables within standard operating expectations.

+ Develop good understanding of the confidential nature of company information and take necessary steps to ensure its protection and compliance with all standards.

+ Create metrics that support PV in understanding performance, compare processes to standards, influence strategic direction, and drive capability improvements within the organization.

Operational Excellence

+ Proactively communicate within the team across geographies, with business teams, vendors, and IT groups to align on safety report requests, business requirements, and delivery timing.

+ Build strong understanding of PV systems data and collaborate with stakeholders in order to ensure reports meet GPS/Lilly/External/Health Authority needs.

+ Apply robust project management principles and ensure seamless execution of projects with complete oversight

+ Develop good understanding of the role of the EU Qualified Person (QP) and ensure support to fulfill the QP legal responsibilities.

Data-Driven Business Solutions & Process Improvements

+ Provide innovative and latest technology solutions as relevant to the business needs such as using Power-BI, Python, AWS services.

+ Demonstrate skill in uncovering valuable insights through data analysis, leveraging cutting-edge techniques and methodologies.

+ Support and contribute to global innovative solutions within PV, in partnership with Tech@Lilly and across functions.

+ Develop good understanding of safety processes in order to lead/participate in projects across PV that drive GPS analytics needs.

Minimum Qualification Requirements:

+ Bachelor’s degree required, preference for health science or information technology

+ 2+ years of experience in the pharmaceutical industry and/or demonstrated understanding of pharmacovigilance or clinical research or similar highly regulated environment.

+ 2+ years of demonstrated experience in data, reporting, analytics, and processes/systems/tools.

Other Information/Additional Preferences:

+ Demonstrated understanding of the PV safety system and business processes

+ Demonstrated working knowledge and application of Computer System Quality (CSQ) requirements.

+ Demonstrated experience with using data analysis and visualization tools (i.e. Excel, Business Objects, Power BI, Tableau, Spotfire, etc.).

+ Experience using Microsoft Tool Suite (i.e. SharePoint, MS Flows, O365, Power Automate, Power Query, Power Apps, Dataverse, etc.)

+ Demonstrate hands-on experience in building models using Regression, Clustering, Classification, Time series Analysis through statistical & ML modelling techniques. Proven experience in Text mining, NLP, NLG and LLM’s

+ Familiarity with Python, R, AI/ML and AWS services for driving analytics projects

+ Proven ability to understand complex business problems and translate them into actionable IT solutions.

+ Ability to work in a global team across geographies and collaborate effectively.

+ Strong interpersonal and project management/leadership skills.

+ Excellent oral and written communication skills.

+ Critical thinking and attention to detail.

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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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

$65,250 - $148,500

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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