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Eli Lilly and Company | Jobs | Associate/Sr. Associate Manager Safety Data Sciences | BigDataKB.com | 10-02-22

Job Location: Bangalore/Bengaluru

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.

System Development Maintenance (40%)

  • Responsible for the support and/or development of new or existing systems, tools, and technologies for GPS
  • Uses standard validation principles and system development methodologies to create and maintain GPS-based applications for use in operations and processes.
  • Strategically influence and drive the change management process for GPS owned systems.
  • Knowledge of data migration/data transfer process involving GPS data.
  • Responsible for the configuration of GPS safety system such as global reporting rules and conducting Product License Study (PLS) activities.
  • Acts as a SME for GPS system configuration activities (i.e. ERR and PLS processes).

Safety Reporting (30%)

  • Supports GPS and Lilly safety reporting needs through the creation of existing/adhoc queries and/or visualizations.
  • Maintains an understanding of GPS systems data in order to ensure reports meet GPS/Lilly needs.
  • Ensures appropriate review and validation of output for accuracy.

Operational Excellence (20%)

  • Provides support to GPS functional areas; interacts with GPS therapeutic teams; facilitates consistency of business practices; assists with the identification and resolutions of process gaps or improvement opportunities; provides input to leadership regarding performance measures and data validation.
  • Proactively communicates with customers, teammates, vendors, and IT groups to align on safety report request requirements and delivery timing.
  • Looks for opportunities to create self-service/enhanced reporting options for GPS/Lilly functional areas.
  • Works across GPS to leverage performance data, compare observations to standards, influence strategic direction, and drive capability improvements.
  • Understanding of safety process knowledge in order to lead/participate in projects across GPS that drive GPS automation, technology and analytics needs.
  • Active engagement in benchmarking in order to highlight opportunities for automation and technology improvements in GPS processes.

Compliance (10%)

  • Provide standard or custom validated reports for use in audits and inspections.
  • Maintains accuracy and performance of routine reports executed by or for GPS.
  • Prepares and maintains records to provide information for summaries, charts, graphs, and monthly or ad-hoc reports.
  • Maintains awareness of existing regulations/guidelines to ensure alignment of deliverables within standard operating expectations.
  • Understands the confidential nature of company information and takes necessary steps to ensure its protection and compliance with all standards.
  • Understand the roles of the EU Qualified Person (QP) and ensures support is provided to fulfill the QP legal responsibilities.

Minimum Qualification Requirements:

  • Masters/Bachelor s degree within a health science, Mathematics, Statistics, Computer Science field or equivalent experience.
  • Demonstrates experience with data, reporting, and processes/systems.

Other Information/Additional Preferences:

  • Experience in the pharmaceutical industry and/or demonstrated understanding of pharmacovigilance or clinical research.
  • Demonstrated understanding of the GPS safety system and business process.
  • Experience working in a highly regulated environment.
  • 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).
  • Experience using Microsoft Tool Suite (i.e. SharePoint, MS Flows, etc.)
  • Ability to work in a virtual team environment.
  • Strong interpersonal and leadership skills.
  • Excellent oral and written communication skills.
  • Process management expertise.
  • Ability to effectively collaborate with others.
  • Critical thinking skills.
  • Attention to detail.
  • Demonstrated ability to deliver to timelines.

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