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Diploma in Pharmacovigilance & Signal Detection – eLearning

$599.00

Online eLearning program without software access.

Looking for hands-on software practice? Explore the Diploma in Pharmacovigilance & Signal Detection with Software Access.

Description

The Diploma in Pharmacovigilance & Signal Detection – eLearning is a comprehensive self-paced online program covering pharmacovigilance, drug safety operations, safety case management and signal detection.

The program builds a foundation in pharmacovigilance before progressing to adverse event management, safety reporting, regulatory requirements, medical coding, risk management, signal detection and safety-data analysis.

Learners also receive structured training in Oracle Argus Safety for safety case management concepts and Oracle Empirica Signal for signal detection, data mining and safety-data analysis.

This eLearning option includes structured tutorials, recorded learning content and software demonstrations. Oracle Argus Safety and Oracle Empirica Signal login access are not included.

Program at a Glance

Pharmacovigilance | Argus Safety | Signal Detection | Empirica Signal

6 Months | Self-Paced eLearning | Certificate on Completion

What You’ll Learn

  • Understand the principles and processes of pharmacovigilance
  • Explore adverse event and safety case management workflows
  • Understand regulatory safety reporting requirements
  • Learn medical coding concepts using MedDRA and WHODrug
  • Understand individual case safety report processing
  • Explore aggregate safety reporting and risk management concepts
  • Understand the principles of signal detection and signal management
  • Explore data mining and disproportionality analysis
  • Become familiar with Oracle Argus Safety workflows and functionality
  • Understand how Oracle Argus Safety supports safety case management
  • Become familiar with Oracle Empirica Signal features and workflows
  • Understand how Oracle Empirica Signal supports signal detection and safety-data analysis

Who Is This Program For?

  • Students and graduates interested in pharmacovigilance and drug safety
  • Pharmacovigilance professionals seeking broader drug safety knowledge
  • Drug safety professionals interested in signal detection and safety analytics
  • Clinical research professionals seeking knowledge of pharmacovigilance processes
  • Pharmacy, life sciences, medical and healthcare graduates
  • Professionals seeking structured training in Oracle Argus Safety and Oracle Empirica Signal
  • Learners seeking combined pharmacovigilance and signal-detection training without software access

Looking for Hands-On Software Training?

If you want to reinforce the pharmacovigilance and signal-detection concepts covered in this program through practical software use, choose the Diploma in Pharmacovigilance & Signal Detection with Software Access.

The software-inclusive option combines the same core training with 24×7 access to both Oracle Argus Safety and Oracle Empirica Signal for the duration of the program.

Explore eLearning + Software

About the Software Training

The program includes structured training, tutorials and software demonstrations covering Oracle Argus Safety and Oracle Empirica Signal.

Learners can develop an understanding of how Oracle Argus Safety supports pharmacovigilance case management and how Oracle Empirica Signal supports signal detection and safety-data analysis.

Software login access to Oracle Argus Safety and Oracle Empirica Signal is not included with this eLearning option.

Explore the Software Covered in This Program

New to pharmacovigilance software? Explore our free ClinSkill learning resources to understand how Oracle Argus Safety supports safety case management and how Oracle Empirica Signal supports signal detection and safety-data analysis.

Learn About Oracle Argus Safety

Learn About Oracle Empirica Signal

Key Features

  • Comprehensive pharmacovigilance and signal-detection curriculum
  • Oracle Argus Safety training through structured tutorials and demonstrations
  • Oracle Empirica Signal training through structured tutorials and demonstrations
  • Coverage of safety case management and medical coding concepts
  • Training in signal detection, data mining and safety-data analysis
  • Flexible, self-paced online learning
  • Quizzes and assessments to reinforce learning
  • ClinSkill Certificate of Completion

Curriculum

Module 1 – Introduction to Clinical Research
  • Pharmaceutical and Clinical Research – Industry Overview
  • Introduction to Clinical Research
  • Stakeholders and Roles in Clinical Research
  • History and Milestones in Clinical Research
  • Principles of Good Clinical Practice
  • Technologies in Clinical Trial Management
  • Overview of Clinical Research Regulatory Bodies
Module 2 – Principles of Pharmacovigilance
  • General Overview of Pharmacovigilance
  • History and aim of Pharmacovigilance
  • Drug dependence
  • Vaccine Vigilance
  • Principles of Signal Detection in Pharmacovigilance
  • Communication in Pharmacovigilance
  • Post-Marketing Surveillance
Module 3 – Pharmacovigilance and Selected System Organ Classes
  • Dermatological ADRs
  • Gastrointestinal ADRs
  • Haematological ADRs
  • Renal ADRs
  • Ocular Side Effects of Prescription Medications
  • Drug Safety in Pregnancy
  • Hepatic Drug Reactions
  • Anaesthetic Adverse Drug Reactions
  • Pharmacovigilance in Pediatrics
  • The Cardiovascular Spectrum of Adverse Drug Reactions
  • Drugs and the Elderly
Module 4 – Pharmacovigilance Systems
  • Audits and Inspections in Pharmacovigilance
  • Pharmacovigilance Department
  • Qualified Person for Pharmacovigilance
  • Standard Operating Procedures in Pharmacovigilance
  • Literature Review
  • MedDRA
  • Eudravigilance
  • Assessment of Compliance
  • Mergers and Acquisitions
  • Softwares used in Pharmacovigilance
Module 5 – Global Pharmacovigilance and Safety Standards
  • WHO & Safety Reporting
  • CIOMS Groups & Functions
  • Good Pharmacovigilance Practice
Module 6 – Pharmacovigilance Regulations and Guidelines
  • Safety Reporting
  • Individual case safety reports
  • Periodic safety update reports
  • Indian Regulations with specific reference to Schedule Y
  • Regulatory Pharmacovigilance in EU
Module 7 – Pharmacoepedemiology
  • Introduction to Pharmacoepidemiology
  • Molecular Genetic Pharmacoepidemiology
  • Analysis of Pharmacoepidemiological Data
  • Studies of Drug Use
  • Case Control Studies
  • Cohort Studies
  • Data Sources
  • Measures of Frequency & Risk
  • Advanced Issues in Pharmacoepidemiology
  • Errors in Pharmacoepidemiology
Module 8 – Oracle Argus Safety Essentials
  • Overview and Navigation
  • Overview of Argus Menus
  • Case Form Features
  • Drug and Event Coding
  • Case Entry and Processing
  • Advanced Conditions
  • Reporting and Submissions
Module 9 – Oracle Empirica Signal
  • Introduction to Signal Detection
  • Introduction to Empirica Signal
  • Signal Detection and Prioritization
  • User Interface – Settings and Features
  • User Interface – Preferences
  • Navigation with Tabs
  • Queries and Case Series
  • Creating Data Mining runs
  • Data Mining Results – Graphical Display
  • Drug Profiles and Reports
  • Empirica Signal Topics
Course Completion
  • Final Assessment
  • Course Certification

The program combines comprehensive pharmacovigilance training with structured learning in Oracle Argus Safety, signal detection and Oracle Empirica Signal.

Both learning options include the same core training curriculum. Oracle Argus Safety and Oracle Empirica Signal login access are not included with this eLearning option.

Certification

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

Duration

The program duration is 6 months, with flexible, self-paced access to the online learning portal.

This eLearning option does not include Oracle Argus Safety or Oracle Empirica Signal software login access.

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