Associate/Sr. Associate Manager Safety Data Sciences
Eli Lilly and Company
Full time- 2+ years
- 50 Lakhs and more
- Bengaluru, India
- Post Date: Mar 14, 2024
- End Date: May 14, 2024
- 2+ years
- 50 Lakhs and more
- Bengaluru, India
- Post Date:Mar 14, 2024
- End Date: May 14, 2024
Skills:
- Operations
- Inspection
- Management
Job Description:
Responsibilities
- Responsible for the support and/or development of new or existing systems, tools, and technologies for GPS systems.
- 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).
- 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.
- 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.
- 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.
Qualification & Experience
- Master's/Bachelor’s degree within a health science, Mathematics, Statistics, Computer Science field or equivalent experience.
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