Diploma in Pharmacovigilance & Signal Detection


Oracle Argus Safety + Oracle Empirica Signal – software access is optional.



The Advanced Diploma in Pharmacovigilance & Signal Detection (ADPV-SD) is designed to provide students a complete understanding of Pharmacovigilance and Signal Detection processes, regulations and documentation. It equips you to start a career in Drug Safety or as a Pharmacovigilance Signal Detection professional. The course is aligned to the requirements of the industry and  includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance and Oracle Empirica Signal for Signal Detection.

Looking for a course that includes 24×7 access to Oracle Argus Safety + Oracle Empirica Signal software? Check out this course


Key Features


  • Full access to e-Learning Portal containing Multimedia Tutorials, Recorded Lectures and Quizzes.
  • Course Instructor support via Discussion Forums


Course Stats – 9 Modules, 73 Chapters, 72 Quizzes


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



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



The duration of this program is 6 months.

You will have access to the course for the duration of the program.


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