Manager – Pharmacovigilance Data Reporting and Analytics at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

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
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

Responsibilities

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
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
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
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

Skills

Key technologies and capabilities for this role

PharmacovigilancePV Data ReportingSQLData AnalyticsUser Acceptance TestingSystem ConfigurationSafety ReportingMetrics DevelopmentChange ManagementRegulatory Compliance

Questions & Answers

Common questions about this position

What is the salary range for this position?

This information is not specified in the job description.

Is this a remote position or does it require working from a specific location?

This information is not specified in the job description.

What key skills are required for this Pharmacovigilance role?

Key skills include proficiency in Power-BI, Python, and AWS services, along with data analysis techniques, project management, and understanding of PV systems and safety processes.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and emphasizes giving the best effort while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this role?

Strong candidates have experience with PV systems, data reporting technologies like Power-BI, Python, and AWS, skills in data analysis and project management, and a good understanding of safety processes and regulations.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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