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Oracle Empirica Signal

(15 customer reviews)

$599.00

Includes 24×7 access to Oracle Empirica Signal for hands-on practice.

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Description

Oracle Empirica Signal is an online training program designed to build knowledge and practical skills in pharmacovigilance signal detection and safety-data analysis using Oracle Empirica Signal.

The program begins with foundational concepts in pharmacovigilance and signal management before progressing to signal detection and prioritization, data mining, disproportionality analysis, application navigation, queries and case series, data mining runs, graphical analysis, drug profiles, reporting and signal topics.

Through structured tutorials, recorded demonstrations and practical software exercises, learners explore how safety data can be analyzed to identify, evaluate and prioritize potential safety signals.

This option combines self-paced eLearning with 24×7 access to Oracle Empirica Signal, allowing learners to apply key signal-detection and data-mining concepts directly within the software.

Program at a Glance

Signal Detection | Data Mining | Safety Analytics

2 Months | 24×7 Empirica Signal Access | Certificate on Completion

What You’ll Learn

  • Understand pharmacovigilance signal-management concepts
  • Explore signal detection, validation and prioritization principles
  • Understand data mining and disproportionality analysis
  • Navigate Oracle Empirica Signal and its key features
  • Work with data configurations and application preferences
  • Create and work with queries and case series
  • Understand the creation and execution of data mining runs
  • Analyze data mining results using graphical displays
  • Explore drug profiles and reporting functionality
  • Understand the use of Topics in signal management

Who Is This Program For?

  • Pharmacovigilance and drug safety professionals
  • Safety reviewers interested in signal detection and management
  • Pharmacovigilance professionals seeking practical exposure to safety-data analysis
  • Clinical research professionals interested in drug safety analytics
  • Pharmacy, life sciences, medical and healthcare graduates
  • Learners seeking hands-on experience with pharmacovigilance signal-detection software

Hands-On Experience with Oracle Empirica Signal

The program includes 24×7 access to Oracle Empirica Signal for the duration of the course, allowing learners to apply signal-detection and data-analysis concepts directly within the software.

Through guided training and practical exercises, learners can explore queries, case series, data mining runs, data mining results, graphical displays, drug profiles, reports and signal-management Topics.

This practical component helps connect pharmacovigilance signal-management concepts with their application in a safety-data analytics environment.

New to Oracle Empirica Signal? Learn more about the application and its role in pharmacovigilance signal detection through our free ClinSkill learning resource: What is Oracle Empirica Signal?

Key Features

  • 24×7 access to Oracle Empirica Signal for hands-on practice
  • Training in pharmacovigilance signal detection and prioritization
  • Practical exercises involving data mining and safety-data analysis
  • Coverage of queries, case series and data mining runs
  • Training in graphical analysis, drug profiles and reporting
  • Recorded sessions and structured multimedia tutorials
  • Quizzes and assessments to reinforce learning
  • Certificate of Completion

Curriculum

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

Certification

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

Duration

The program duration is 2 months, with flexible, self-paced access to the online learning portal.

Learners enrolled in this software-inclusive option also receive 24×7 access to Oracle Empirica Signal for the duration of the program.

15 reviews for Oracle Empirica Signal

  1. Janna Gordon (verified owner)

    Very good program for learning the basics of signal detection and Empirica Signal software. Recorded demonstrations to follow. Access to Empirica test environment to practice skills learned. Staff very responsive to questions.

  2. Akina Teikoku

    Just completed this program. As promised on the course description page received access to the latest version of Empirica Signal 9.2 which is great as i did not come across any other institution offering this latest version. Most institutions offer access to Empirica 7 which is already redundant. The recorded sessions help me learn and practice at my pace. Very glad i went for this program!

  3. Paul Peters

    Great program. Learnt several practical aspects of signal detection in pharmacovigilance using the Oracle Empirica Signal software which were useful in my job as a safety reviewer.

  4. Diksha Patil

    Niche course on Signal detection using Oracle Empirica Signal. Received access to the software as promised and the recorded sessions were clear and comprehensive. Would recommend this course!

  5. Nighat Ali (verified owner)

    The best thing about this place is, the help which Nitin provides. The faculty response time is very good too. But for me Nitin found out the issue, it was I guess technical. I was ready to give up with this course and the Clinskill academy. It was a last resort that I contacted Nitin. he is excellent, especially realizing that although it daytime for me , he is working night. I do hope he is being paid good bucks. Five stars for Nitin and Clinskill

  6. Mirabel Weriwoh (verified owner)

    I recommend this course to any individual who is interested in both the knowledge and practical aspect of Empirica Signal for signal detection. I truly liked the fact that, I had access to the Empirica Signal software and at an affordable cost as well. Very organized and structured program. Wonderful and amazing faculty and staff support. Thanks Clinskill faculty and staff for all your amazing support!!!!!!

  7. Tapsi

    Recommend this course. Detailed and explanatory. But i recommend should have knowledge of Pharmacovigilance and case processing before taking this up.

  8. Amal Bashir

    Just what i was looking for. Upgraded me from a Pharmacovigilance Associate to a high-demand Pharmacovigilance Signal Detection professional. Recommend it!

  9. 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.

  10. 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.

  11. Sukanta Rao

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

  12. 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!

  13. 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.

  14. 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!

  15. Maria Garcia

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

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