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Diploma in Pharmacovigilance

(20 customer reviews)

$799.00

Includes 24×7 access to Oracle Argus Safety for hands-on practice.

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Description

The Diploma in Pharmacovigilance is a comprehensive online program designed to build knowledge and practical skills in pharmacovigilance and drug safety. The program combines structured, self-paced learning with multimedia tutorials, recorded sessions, quizzes, assessments and hands-on experience using Oracle Argus Safety.

Covering 8 modules, 63 topics and 62 quizzes, the program begins with an introduction to clinical research before progressing to pharmacovigilance principles, adverse drug reactions, pharmacovigilance systems, global safety standards, regulatory requirements and pharmacoepidemiology.

You will explore key areas of drug safety including adverse event management, Individual Case Safety Reports (ICSRs), safety reporting, MedDRA, literature review, Good Pharmacovigilance Practices, periodic safety reporting and post-marketing surveillance.

The program also includes dedicated practical training using Oracle Argus Safety, helping you connect pharmacovigilance concepts with the management and reporting of drug safety data in a practical software environment.

Program at a Glance

8 Modules | 63 Topics | 62 Quizzes

3 Months | 24×7 Software Access | Certificate of Completion

What You’ll Learn

  • Principles of pharmacovigilance and drug safety
  • Adverse drug reactions and post-marketing surveillance
  • Pharmacovigilance systems, processes and documentation
  • Individual Case Safety Reports (ICSRs) and safety reporting
  • MedDRA and medical coding concepts
  • Global pharmacovigilance regulations and safety standards
  • Good Pharmacovigilance Practices
  • Periodic and aggregate safety reporting
  • Pharmacoepidemiology and safety data analysis
  • Drug safety case management using Oracle Argus Safety

Who Is This Program For?

  • Students and graduates interested in pharmacovigilance and drug safety
  • Pharmacy, life sciences, medical and healthcare graduates
  • Healthcare professionals exploring pharmacovigilance
  • Professionals transitioning into pharmacovigilance or drug safety
  • Pharmacovigilance professionals looking to strengthen their knowledge across key functional areas
  • Learners seeking hands-on exposure to drug safety software

Hands-On Experience with Oracle Argus Safety

The program includes 24×7 access to Oracle Argus Safety for the duration of the program, allowing you to apply pharmacovigilance concepts in a practical software environment.

Through dedicated software training, you will explore key drug safety activities including case entry and processing, case triage, drug and event coding, medical review, narrative writing, quality control, and safety reporting and submissions.

This practical component helps you connect pharmacovigilance processes with their application in a drug safety system and develop hands-on familiarity with workflows used to manage safety data.

New to pharmacovigilance? Explore our free learning resource on What is Pharmacovigilance

Explore more Pharmacovigilance courses and training programs.

Key Features

  • Comprehensive pharmacovigilance curriculum covering key drug safety concepts and processes
  • 8 modules, 63 topics and 62 quizzes
  • Multimedia tutorials and recorded sessions
  • 24×7 access to Oracle Argus Safety
  • Hands-on training in drug safety case management activities
  • Quizzes and assessments to reinforce learning
  • Instructor support through discussion forums
  • 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 – Pharmacoepidemiology
  • 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
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 duration of this program is 3 months.

You will have access to the course, and Oracle Argus Safety software for the duration of the program.

20 reviews for Diploma in Pharmacovigilance

  1. Imani Rout

    Access to latest version of Oracle Argus Safety 8.2.3.1 received as part of this program. I was sold at this because from my friend i heard hands on experience on the latest version with latest regulations is a must and that what interviewers looked for. The recorded sessions help me navigate the software. Very useful program for me as i explore a career in drug safety!

  2. Chantria

    Good but detailed program. Don’t expect to just browse through it. Join this if you are committed to mastering pharmacovigilance.

  3. Dr. Zeba Onkaran

    Explored programs across several providers and narrowed down on this one specifically because it offers access to the Argus software which is required by the industry. Was surprised by the depth of content. The content comprehensively covers all aspects of PV along with practical training on Argus Safety. Would highly recommend this course.

  4. Haruko

    This is by far the most comprehensive course in pharmacovigilance that i have explored. Argus Safety which is the software used to collect and manage drug safety data is included in this course which makes is super useful.

  5. Nikhil Bhatia

    Excellent content from the Instructor. Easy to understand and Argus Safety software access made the course engaging with practical examples.

  6. Simi

    Detailed program. Covered all aspects of drug safety including Oracle Argus.

  7. Malvika (verified owner)

    This is my first time, trusting on a elearning platform. Diploma in Pharmacovigilance covers all you need to know about PV as a beginner and gave me hands on experience over Argus safety software. More over, the discussion forum is the most helpful tool. You can anytime post your query and they will revert back within a day or 2. Their customer care team, is very helpful. Have no complains. Will take more courses from them!

  8. Anisha Patel

    Comprehensive course. Covers theoretical and practical aspects of Pharmacovigilance. Support was great.

  9. Priya Bhasin

    Just enrolled for the program. Got access to the course and software instantly as promised. So far i am happy with what i have experienced. Will write a full review once i complete the program..

  10. Tahir Pescha

    Detailed program with access to Argus Safety. Helped me immensely while preparing for an Interview for a Drug safety position. I am happy I found this program.

  11. Nawang Tsering

    This was the first time i have enrolled for an eLearning program. The content is really clear and very comprehensive at the same time. The quizzes make learning more engaging and i did not face any problem accessing the Argus Safety software. I am learning from the modules and have found this course really useful so far. By working practically on cases in Argus safety i am getting confident in managing cases. Recommend it!

  12. Nicole Longo (verified owner)

    As a board-certified physician, I have found this course extremely useful and relevant not only to clinical practice, but to those clinicians looking to expand their opportunities into the pharmaceutical and non-clinical spectrums. Some of the course information covered would have been appropriate to have presented within medical school training and is absolutely applicable to current clinical practice. I am pleased to say that I have learned valuable, clinically relevant information that I can use today, even without a transition to the pharmaceutical environment. Highly recommend this course and found the course trainer(s) extremely helpful in all questions. Only suggestion would be for the course material video slide presentations to have the option to slow down the audio; my function (if available) did not work and listening to lectures with accents not natural to my own did present somewhat challenging, requiring repeated listening to grasp the material.
    Thank you!!

  13. Tara Mehndiratta

    Enrolment was instant and i didn’t have to follow up with anybody via email. Faculty was responsive and patient in addressing my queries. Access to actual Argus Safety software was provide, not some knock-off application for pharmacovigilance. Impressed!

  14. Ankit Fadia

    Look no further. Audio tutorials help simplify the concepts. They have an app through which you can download and access the content offline and also take your quizzes while travelling. Helped me learn while on the job. No regrets.

  15. Snighda Sharma

    Very informative!

  16. Leslie

    Took this course with very basic knowledge of Pharmacovigilance. On completing this program i feel i have the subject matter expertise to make a career in this field. Working on the software helped me practice and become confident. Great course!

  17. Pooja Phogat

    24×7 access to Oracle Argus Safety software for practice. Couldn’t have asked for more. Helped me get the practical experience. Got a job as a Drug Safety associate with Paraxel!

  18. Rahul Vij

    Recommend it!

  19. Mark Villaneula

    Joined this program. Very detailed course that includes loads of Tutorials. Quizzes at end of each chapter are great way to check my knowledge before moving on the next topic.

  20. Ritika Walia

    Detailed program in Pharmacovigilance. Covers basics of clinical research, pharmacovigilance processes and how to manage drug safety data using Oracle Argus Safety software. If you are starting a career in pharmacovigilance, this course is just right for you.

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