The Professional Diploma in Pharmacovigilance (PDPV) is an online eLearning course that covers the core concepts of management of drug safety data and equips you to start a career in Pharmacovigilance domain. The course is aligned to the requirements of the industry and imparts process knowledge of how drug safety data is managed in a clear and concise manner so that you may kickstart a career in pharmacovigilance.
The course includes hands-on practical training on Oracle Argus Safety software used as a de-facto standard for managing drug safety data.
The Diploma in Pharmacovigilance program is made up of 8 modules, 63 topics and 62 Quizzes. It covers the overview of clinical research, pharmacovigilance processes, drug safety regulations and pharmacovigilance systems.
The final module of the course covers the process of managing drug safety data using the Oracle Argus Safety application. This module covers all the pharmacovigilance tasks performed in Oracle Argus Safety including Case entry, Case Triage, Medical coding, Medical review, Narrative writing, Quality control and Reporting.
On completing your enrolment for the Diploma in Pharmacovigilance program you will instantly get access to our online learning portal and the Oracle Argus Safety software.
This course includes access to latest version of Oracle Argus Safety – version 18.104.22.168 for hands on practical experience.
Find more information about the field of Pharmacovigilance – What is Pharmacovigilance.
Course Stats – 8 Modules, 63 Chapters, 62 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
- 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
- Final Assessment
- Course Certification
At the end of the course, students will be awarded a certificate of completion.
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.
Imani Rout –
Access to latest version of Oracle Argus Safety 22.214.171.124 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!
Good but detailed program. Don’t expect to just browse through it. Join this if you are committed to mastering pharmacovigilance.
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.
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.
Nikhil Bhatia –
Excellent content from the Instructor. Easy to understand and Argus Safety software access made the course engaging with practical examples.
Detailed program. Covered all aspects of drug safety including Oracle Argus.
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!
Anisha Patel –
Comprehensive course. Covers theoretical and practical aspects of Pharmacovigilance. Support was great.
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..
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.
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!
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.
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!
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.
Snighda Sharma –
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!
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!
Rahul Vij –
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.
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.