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.

Analyst/Associate/Sr. Associate – Pharmacovigilance Data Reporting and Analytics

Purpose:

The purpose of the role of PV Data Reporting and Analytics- Analyst/Associate/Sr. Associate is to support PV operations via data analysis, reporting, key performance measures and technology solutions for process improvements. This role must have a technical understanding of various PV data sources so that they can effectively create/execute reports and provide guidance/interpretation of data for various organizations including case management, surveillance, quality, investigator sites, and medical personnel. They will work with stakeholders to analyze workflows and business processes to identify improvement opportunities, productivity enhancements, and increased quality of data and process; and will be responsible for the support development of new or existing systems, tools, and technologies for PV.

Primary Responsibilities:  This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional
responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1. 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.

2. 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.

3. 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.

4. 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 within health science, information technology or equivalent experience.
• Demonstrated experience in data, reporting, analytics, and processes/systems/tools.
• Experience in the pharmaceutical industry and/or demonstrated understanding of pharmacovigilance or clinical
research or similar highly regulated environment.

Other Information/Additional Preferences: 
• Relevant experience in the area
• 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.