Oracle Empirica Signal

Associated Courses
(7 customer reviews)





Oracle Empirica Signal is an e-Learning program that covers all the topics from Signal detection, through their validation and confirmation, analysis, prioritization and assessment to recommending action, as well as the tracking of the steps taken and of any recommendations made using the Oracle Empirica Signal application.

Key Features

  • 24×7 access to the Oracle Empirica Signal software
  • Full access to eLearning Portal containing  Tutorials, Quizzes and Assessments
  • Full access Recorded sessions
  • Course Instructor support via Discussion Forums


Chapter 1 – Introduction to Signal Detection
  • Define Pharmacovigilance and Learn about the Evolution of Pharmacovigilance
  • Understand the Pharmacovigilance process
  • Determine the Rationale for Pharmacovigilance
  • Define Pharmacoepidemiology, Signals and Risk Management  in Pharmacovigilance
  • Understand process of Signal Management in Pharmacovigilance
  • Determine the Benefit Risk Profile in Pharmacovigilance
Chapter 2 – Introduction to Empirica Signal
  • Empirica Signal – Definition
  • Source Data
  • Data Configurations
  • Data Mining Runs
  • Data Mining Results
  • Queries and Reports
  • Drug Profiles
  • Topics
Chapter 3 – Empirica Signal – Signal Detection and Prioritization
  • Signal Detection
  • Data Mining
  • Data Mining Statistics
  • Signal Prioritizing
  • Disproportionality Analysis
  • Benefits of Signal Detection and Prioritization
  • False Alarms
  • Signal Detection Comparison Methods
  • Signaling Sensitivity and Specificity
Chapter 4a – User Interface – Settings and Features
  • Empirica Signal Web Configuration
  • Software Features
  • Settings
  • User Permissions
  • System Configurations
Chapter 4b – User Interface – Preferences
  • Data Configurations
  • Drug Profile Configurations
  • Workflow States
  • Topic Workflow Configurations
  • User Preferences
Chapter 5 – Navigating with Tabs
  • Home
  • Drugs
  • Data Mining Runs
  • Data Mining Results
  • Queries
  • Case Series
  • Reports
  • Topics
Chapter 6 – Queries and Case Series
  • Queries
  • Case Series
Chapter 7 – Creating Data Mining runs
  • Data Mining
  • Data Mining Uses
  • Data Mining Runs – Database Restriction
  • Data Mining Runs – Create MGPS Run
  • Data Mining Runs – Parameters
  • Data Mining Runs – Custom Terms
  • Data Mining Runs – Subsets
  • Data Mining Runs – Create LR Run
  • Data Mining Runs – Variables & Variable selection
Chapter 8a – Data Mining Results
  • Understand Data Mining Results
Chapter 8b – Data Mining Results – Graphical Display
  • Data Mining Results – Graphs
  • Graph Cut point and Palette Choices
  • Bar Graph
  • Confidence Interval Bar Graph
  • Discrete Map Graphs
  • Cumulative Map Graphs
  • Sector Maps
  • Nested Confidence Interval Graph
  • Hierarchy Graph
  • Overlap Graph
Chapter 9 – Drug Profiles and Reports
  • Drug Profile
  • Drug Profile Configuration
  • Drug Profile Layout
  • Drug Profile Manage Layout
  • Reporting Feature
  • Report Structure
  • Report Definition
  • Report Batch Runs
Chapter 10 – Empirica Signal Topics
  • Topics
Course Completion
  • Final Assessment
  • Course Certification


At the end of the course, students will be awarded a certificate of completion.



The duration of this program is 2 months.

7 reviews for Oracle Empirica Signal

  1. Maria Garcia

    Recorded sessions were very helpful! Faculty demonstrated all features of Oracle Empirica Signal software and how they are used for Signal detection.

  2. Tanya Meher

    Received access to Oracle Empirica Signal. Helped me practice on creating and executing data mining runs on pharmacovigilance case data to understand how signals are detected. Great experience!

  3. Kiran Shah

    Faculty was very responsive. Provided answers to all my queries. Quizzes after each chapter helped me very much. Overall really liked the course.

  4. Catherine Goetz

    I am an experienced Pharmacovigilance professional and wanted to specialise in Signal Detection in Pharmacovigilance. Researched a lot of training institutes. Either they were only teaching theory of Signal detection in pharmacovigilance or just had a couple of chapters on this subject as part of their pharmacovigilance program. This program specifically covers Signal detection in Pharmacovigilance in great level of detail and provides access to the Oracle Empirica Signal software. This helped me get the practical knowledge. If you are planning to go into Signal detection in PV, don’t look any further. Really happy to have persued this program!

  5. Sukanta Rao

    Received 24×7 access to Oracle Empirica Signal software. Helped me learn real-time on actual cases. Recommend this program.

  6. Rayan Kasju

    Just completed this program and found it extremely useful. The access to Empirica Signal software gave me the necessary practical experience. I am more confident now to apply for positions in signal detection in drug safety.

  7. Erica Young

    Just completed this program and i would recommend it for the quality of the instructions and the ability to access the Empirica software and practice on the concepts learnt.

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