
Analytics and Data Visualization
01
What Pharmaceutical Firms Look For
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A robust data analytics framework that enables comprehension of patient safety data and extraction of valuable insights
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Tailored periodic reports designed for submission to Health Authorities
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An analytical solution for monitoring daily case processing activities
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Support for ongoing business operations, assisting various departments within Drug Safety
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Assistance with audits and inspections by providing requested data to Health Authorities
02
How We Can Help
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Demonstrate expertise in providing reporting and analytics solutions utilizing Patient Safety Data.
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Proficient in utilizing reporting tools like IBM Cognos, SAP Business Objects, and Oracle OBIEE
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Implement highly efficient dashboards using Tableau and Spotfire to present data in an interactive manner for quick and informed business decision-making
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Possess a strong understanding of database architecture design for Argus Safety, Insight, and Argus MART
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Develop custom reports and standard listings in compliance with the latest Regulatory Guidelines
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Conduct requirement gathering, and create user, functional, and design specifications
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Thoroughly draft, test and validate reports through Operational Qualification (OQ) and Performance Qualification (PQ)
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Prepare user training materials to ensure effective utilization of the reporting system
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Establish data extraction processes following the Software Development Life Cycle (SDLC) framework
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Update custom periodic reports to align with the most recent Health Authority guidelines
03
Key Reports
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Standard Safety Search
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Submission Compliance Report
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Workflow Monitoring Report and Dashboard
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CIOMS II Line Listing
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Signal Detection
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Tailored Periodic Reports – PBRER, DSUR, PSUR, PADER
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Comprehensive Case Duplicate Search Report
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Audit Log Search Report
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ESM Reports