The Advanced Postgraduate Diploma in Pharmacovigilance & Clinical Data Management is a robust 6-month online program aimed at pharmacy, clinical research, biotech, and allied health graduates seeking to specialize in drug safety and data integrity. It delivers an in-depth curriculum across three modules—Clinical Data Management fundamentals, advanced CDM practices such as data validation, eCRF management, query resolution, medical coding, and regulatory quality systems, and Pharmacovigilance topics including global regulations, adverse event reporting, causality assessment, signal detection, risk–benefit analysis, MedDRA usage, ICSRs, and PSUR preparation. Designed for online convenience via a Moodle-based portal, the program includes expert-authored eBooks, online assessments, and hands-on learning. Graduates receive an industry-recognized certificate and performance card, preparing them for roles like Data Manager or Drug Safety Associate. The course also includes placement support through resume assistance, interview prep, and job alerts via PharmaExa partner network.
If you are an international student, meaning you reside outside of India, please note that your course fee must be paid in US Dollars (USD). This pricing structure applies specifically to students enrolling from countries other than India.
To ensure smooth and secure transactions, all international payments must be made through PayPal only. We do not accept bank transfers, UPI, or any other local payment methods for international registrations.
When registering, please select your desired Diploma Certification program from the dropdown menu, enter your email address and contact number, and click the “Buy Now” button to proceed with the PayPal payment.
If you face any issues or need further assistance, feel free to contact our support team.
This Advanced PG Diploma is a globally recognized, 100% online certification program designed to prepare you for high-demand roles in Pharmacovigilance and Clinical Data Management. With expertly curated content, you’ll gain in-depth knowledge of drug safety reporting, adverse event handling, MedDRA coding, and data validation used across pharmaceutical companies and CROs. The program includes structured modules, downloadable eBooks, and online assessments to track your progress.
You’ll also receive end-to-end placement assistance — including resume building, interview preparation, and job alerts — through our placement partner JobsAvenue.net, with your profile being shared across 150+ pharma and healthcare organizations. Ideal for final-year students and working professionals, this course helps you build industry-relevant skills, improve your employability, and kickstart a successful career in clinical research and drug safety — all from the comfort of your home.
Advanced Post Graduate Diploma in Pharmacovigilance and Clinical Data management
Designed primarily for students of pharmacy, clinical research and allied health professions, Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology and contract research organization industries who wish to gain a broader understanding of study design, data validation, data entry system tools, data programming and e-learning software.
Pharmacovigilance is critical to ensure the continued safety of drugs, as information on potential harms of a drug is incomplete when the drug is launched. Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Pharmacovigilance begins at the clinical stage and continues throughout the life cycle of the drug, mainly divided as pharmacovigilance during the clinical phase and post marketing. The process of collection of such information about a drug begins in phase I of the clinical trial, before approval of the drug, and continues even after approval; several post-market safety studies are conducted, with many made mandatory by drug regulatory agencies around the world.
We have divided the course in three modules. In First module, we cover the basic aspects of Clinical Data Management. In the second module, we cover core CDM knowledge like data validation and data development. In the third modules, we cover Pharmacovigilance knowledge like the regulations, signal detection, risk benefit analysis, medical dictionaries,
• To provide a comprehensive introduction to the Clinical Data Management process and Pharmacovigilance and Global Pharmacovigilance regulations.
• Learn the skills, knowledge and competencies of a candidate for the CDM.
• Practical aspects of important Pharmacovigilance activities as per the global standards like medical evaluation, casualty assessment, expectedness assessment, case narratives, MedDRA, case processing preparation of safety report etc
• Become more familiar with roles/jobs as part of the study team.
• Understanding of Databases , management of clinical data and Pharmacovigilance.
• Understanding of key enterprise clinical data management tools and Pharmacovigilance safety
MODULE -1
Module -2 Pharmacovigilance
You can also view our FAQs page for further queries.
– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
Student 3200
Length: 4 weeks
Timings: Self Paced
Language: English
Effort: 55 hrs. approx
Skill Level: All
[wprevpro_usetemplate tid=”1″]
Diploma in Clinical Research || Advanced PG Diploma in Clinical Research & Pharmacovigilance || Advanced PG Diploma in Clinical Research & Clinical Data Management || Advanced PG Diploma in Pharmacovigilance & Clinical Data Management || CCRC - Certified Clinical Research Coordinator || CCRA - certified Clinical Research Associate || Clinical Trial SAS Programmer || CRP - Certified Clinical Research Professional
Welcome to PharmaExa. India is becoming a hub for Clinical Research; the demand for professionals in this field is growing rapidly
Privacy & Policies
Department of Industrial policy & Promotion, Ministry of Commerce & Industry, Government of India.
