Empirica Signal      2 months

Oracle Empirica Signal is an e-Learning program that covers the basic and advanced concepts of performing signal detection in pharmacoviglance using the Oracle Empirica Signal application.

Key Features

Here’s how you learn

Access to Empirica Signal

Get hands-on practical experience on conducting pharmacovigilance signal detection by working on the Oracle Empirica Signal software.

Recorded Sessions

Get access to recorded video lectures from our expert industry faculty that demonstrate all activities performed in Oracle Empirica Signal.

Multimedia Tutorials

Our tutorials are handcrafted for a holistic learning experience. Access Computer Based Trainings (CBTs) on all Oracle Empirica Signal activities.

Quizzes and Assessments

The program includes a Quizzes and Practical Assignments for each chapter to assess you understanding of the subject and provide feedback.

Discussion Forums

Each chapter includes a Discussion Forum. Post your Question. Get an answer from our Faculty. Its really that simple!.

Certificate of Completion

Earn Badges as you learn. Download the Certificate of Completion when you meet the course completion criteria for the program.


Here’s what you learn

Chapter 1 : Introduction to Signal Detection

In this chapter you shall learn the process of pharmacovigilance, its rationale and importance of signals and risk management in pharmacovigilance. You will also learn about management of signals and determination of benefit risk profile in pharmacovigilance.


Chapter 2 : Introduction to Empirica Signal

In this chapter we shall discuss the definition of Empirica Signal, identify source data, setup data configurations, create data mining runs, generate data mining results, generate queries and reports, create drug profiles and concept of Topics in Empirica Signal.


Chapter 3 : Signal Detection and Prioritization

In this chapter we shall discuss the process of Signal detection, Data mining, Data mining statistics, Signal prioritization, Disproportionality Analysis, Benefits of Signal Detection and Prioritization, False Alarms, Signal Detection Comparison Methods and Signalling Sensitivity and Specificity.


Chapter 4a : User Interface – Settings and Features

This chapter will cover Empirica Signal Web Configuration, Software Features, Settings, User Permissions and System Configurations.


Chapter 4b : User Interface – Preferences

This chapter covers Data Configurations, Drug Profile Configurations, Workflow States, Topic Workflow Configurations and User Preferences.


Chapter 5 : Navigating with Tabs

This chapter covers the various Tabs of the Oracle Empirica Signal application. This includes the tabs of Home, Drugs, Data Mining runs, Data Mining results, Queries, Case series, Reports and Topics.


Chapter 6 : Queries and Case Series

This chapter describes the concept of Queries and Case series in Empirica Signal.


Chapter 7 : Creating Data Mining runs

In this chapter we shall discuss about various aspects of Data Mining, its uses, Database restrictions, creating MGPS runs, Parameters, Custom Terms, Subsets, creating LR Run as well as Variables & Variable selection.


Chapter 8a : Data Mining results

In this chapter we shall learn about Data mining results.


Chapter 8b : Data Mining Results – Graphical Display

In this chapter we shall discuss about 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 and Overlap Graph.


Chapter 9 : Drug Profiles and Reports

In this chapter we shall discuss about Drug Profiles, Drug Profile Configuration, Drug Profile Layout, Drug Profile Manage Layout, Reporting Feature, Report Structure, Report Definition and Report Batch Runs.


Chapter 10 : Empirica Signal Topics

In this chapter we shall discuss about the use of Topics in Empirica Signal.


Course Completion

This course completion module, includes a Final Quiz that you will need to take to complete this course. The marks of the final quiz will be added to the marks of all other graded activities of this course. If your total score in the course is 75% and above, you will be able to see a Course completion certificate which you can then download.


Mitchelle Adams


“Oracle Empirica Signal was a comprehensive course and helped me understand all the concepts of signal detection, assessment and reporting in pharmacovigilance. The concepts were clearly explained and demonstrated by the Instructor. Queries posted in the discussion forums were addressed in time. The access to the software makes this course stand out as it gives you the hands on experience on signal detection. I would recommend this course. “

Course Fee

Choose a Learning style that suits you.


Here are some questions we get asked often about this course

What is Oracle Empirica Signal?

Oracle Empirica Signal is a software application used for signal detection in pharmacovigilance that uses data from Adverse Events and Serious Adverse Events (SAEs) generated during clinical trials. It is used by most of the Fortune 500 companies. It is a part of a larger suite of applications called the Oracle Pharmaceutical applications suite (OPA)..

Do you offer a Live Online Training program?

Yes. The Oracle Empirica Signal – Live Online Training program is delivered through WebEx. We will schedule your lectures with the Instructor and Live Online classes shall be conducted via WebEx. In addition, you will also have access to recorded sessions, tutorials and assignments.

Will i get access to Oracle Empirica Signal software?

Yes, you will be able to access the Empirica Signal application 24×7 from your home throughout the duration of the program. Your credentials to access the software shall be emailed to instantly on enrollment in the program. It is a web-based application and no installation is necessary.

Do i receive a Certificate of Completion?

On successful completion of the program, students will be awarded a Certification. We lay a strong focus on the quality of learning. To acheive ceritication, you will need to complete all graded Tutorials, Quizzes, Assignments and a Final Examination at the end of the program.

What is included in Oracle Empirica Signal?

Oracle Empirica Signal is an eLearning program and is designed to be a self-paced learning course. You will get access to our Online Learning Portal and will learn through recorded sessions, tutorials and assignments. You can get your queries answered through Support Tickets and Discussion forums.

Can i upgrade after sign-up?

Yes. You can upgrade from the Oracle Empirica Signal – eLearning to the Empirica Signal – Live Online program at any time after signing up. You will only need to pay the difference in Fee. You can request an upgrade to the Live Online course by raising a support ticket on our Support Portal.

Who will answer my Queries?

Every chapter in the course will have a Discussion forum. When you post a query in the Forum, the Course instructor will reply to it. You can also directly message the course instructor from within the Learning portal. For urgent inquires you can also raise a support ticket on our Support Portal.

What jobs am i eligible for after the Course?

On successful completion of the program you will be eligible for the roles of a Drug Safety Associate, Pharmacovigilance officer, Drug Safety Data Manager, Pharmacovigilance Scientist, Risk Management Specialist, Senior Vigilance Manager and Signal Detection Specialist.

Ready to get started?

Get in touch, or enroll in the course