The Advanced Postgraduate Diploma in Pharmacovigilance & Drug Regulatory Affairs (PGD-PV & DRA) is a comprehensive 6-month online program designed for graduates from pharmacy, clinical research, biotechnology, life sciences, and allied health sciences who aim to build a specialized career in drug safety, regulatory compliance, and data integrity.
This program provides in-depth knowledge of pharmacovigilance systems and global regulatory frameworks, enabling learners to understand the complete lifecycle of drug development, safety monitoring, and regulatory submissions. The curriculum is structured to combine theoretical foundations, practical exposure, and industry-oriented learning, ensuring job readiness.
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This Advanced PG Diploma is a globally recognized, 100% online certification program designed to prepare learners for high-demand roles in Pharmacovigilance and Drug Regulatory Affairs. With expertly curated content, participants gain in-depth knowledge of drug safety reporting, adverse event management, MedDRA coding, safety signal evaluation, aggregate reporting, and global pharmacovigilance regulations followed across pharmaceutical companies and CROs.
The program features structured learning modules, expert-authored downloadable eBooks, and online assessments to monitor progress and reinforce conceptual understanding. Learners also receive theoretical exposure to industry-standard pharmacovigilance tools, ensuring alignment with real-world drug safety practices.
In addition, the course offers end-to-end placement assistance, including resume development, interview preparation, and job alerts, through the placement partner JobsAvenue.net, with candidate profiles shared across 150+ pharmaceutical and healthcare organizations. Ideal for final-year students, fresh graduates, and working professionals, this program helps build industry-relevant pharmacovigilance and regulatory skills, enhances employability, and supports a successful career in drug safety and regulatory affairs—all through flexible online learning.
Advanced Post Graduate Diploma in Pharmacovigilance and Clinical Data management
The Advanced Postgraduate Diploma in Pharmacovigilance & Drug Regulatory Affairs is a comprehensive 6-month online program designed for graduates and professionals from pharmacy, clinical research, biotechnology, life sciences, and allied health sciences who aspire to build a career in drug safety and regulatory affairs within the pharmaceutical and biotechnology industries.
Pharmacovigilance is a critical discipline that ensures the ongoing safety of medicinal products, as complete safety data is often unavailable at the time of drug approval. It is the science concerned with the detection, assessment, understanding, and prevention of adverse drug reactions, covering both short-term and long-term effects. Pharmacovigilance activities begin during the clinical trial phases and continue throughout the entire life cycle of a drug, including post-marketing surveillance, as mandated by global regulatory authorities.
This program is structured into two core learning streams: Pharmacovigilance and Drug Regulatory Affairs.
The Pharmacovigilance curriculum provides in-depth knowledge of global drug safety systems and practices, including:
Introduction to Pharmacovigilance
Signal Detection and Causality Assessment
Statistical Reasoning and Algorithms in Pharmacovigilance
Medical Dictionary for Drug Regulatory Activities (MedDRA)
Individual Case Safety Reports (ICSRs)
Pharmacovigilance Aggregate Reports
Periodic Safety Update Reports (PSURs)
Oracle Argus Safety – Theoretical Software Training
Online Examination
The Drug Regulatory Affairs curriculum offers a comprehensive understanding of regulatory requirements across the drug development lifecycle and includes:
Regulatory considerations for Investigational New Drug (IND) applications
Clinical study and start-up activities
Overview of Clinical Trial Phases I, II, and III
Industry and regulatory expectations during late-phase clinical trials
New Drug Application (NDA) filing procedures and product labeling
Regulatory documentation and compliance requirements
Online quiz and assessments
The program is delivered through an online learning platform, offering flexibility for students and working professionals. Learning resources include expert-authored study materials, assessments, and theoretical exposure to industry-standard pharmacovigilance software.
Upon successful completion, learners receive an industry-recognized certification and performance evaluation, preparing them for roles such as Drug Safety Associate, Pharmacovigilance Executive, PV Case Processor, Regulatory Affairs Associate, and Clinical Research support roles.
The program also includes placement assistance, such as resume development, interview preparation, and job alerts through an industry partner network, supporting learners in their transition into the pharmaceutical and life sciences workforce.
Module -1 Pharmacovigilance
Module -2 Drug Regulatory Affairs
| Chapter 1 | 1 – Regulatory Considerations when filling an investigation new drug application | |
| Unit 1 | Lecture regulatory Considerations When Filing An Investigation New Drug Application I-1 | |
| Unit 2 | Regulatory Considerations When Filing An Investigational New Drug Application Ii-2 | |
| Unit 3 | Regulatory Considerations When Filing An Investigational New Drug Application Iii-3 | |
| Unit 4 | Regulatory Considerations When Filing An Investigational New Drug Application Iv-4 | |
| Unit 5 | Regulatory Considerations When Filing An Investigational New Drug Application V-5 | |
| Chapter 2 | 2. Clinical Study & Start-up Activities Part | |
| Unit 1 | Clinical Study & Start-up Activities I-1 | |
| Unit 2 | Clinical Study & Start-up Activities II-2 | |
| Unit 3 | Clinical Study & Start-up Activities III-3 | |
| Unit 4 | Clinical Study & Start-up Activities IV-4 | |
| Unit 5 | Clinical Study & Start-up Activities V-5 | |
| Chapter 3 | 3. Clinical Trials Phase 1 | |
| Unit 1 | Clinical Trials Phase 1 Part I-1 | |
| Unit 2 | Clinical Trials Phase 1 Part II-2 | |
| Unit 3 | Clinical Trials Phase 1 Part III-3 | |
| Unit 4 | Clinical Trials Phase 1 Part IV-4 | |
| Unit 5 | Clinical Trials Phase 1 Part V-5 | |
| Chapter 4 | 4 – Clinical Trials Phase 2 | |
| Unit 1 | Clinical Trials Phase 2 Part I-1 | |
| Unit 2 | Clinical Trials Phase 2 Part II-2 | |
| Unit 3 | Clinical Trials Phase 2 Part III-3 | |
| Unit 4 | Clinical Trials Phase 2 Part IV-4 | |
| Unit 5 | Clinical Trials Phase 2 Part V-5 | |
| Chapter 5 | 5 – Industry Considerations with Phase 3 Clinical Trials Part | |
| Unit 1 | Industry Considerations with Phase III Clinical Trials I-1 | |
| Unit 2 | Industry Considerations with Phase III Clinical Trials II-2 | |
| Unit 3 | Industry Considerations with Phase III Clinical Trials III-3 | |
| Unit 4 | Industry Considerations with Phase III Clinical Trials IV-4 | |
| Unit 5 | Industry Considerations with Phase III Clinical Trials V-5 | |
| Unit 6 | Industry Considerations with Phase III Clinical Trials V-5 | |
| Chapter 6 | 6 – New Drug Application, Filling, Product Labeling | |
| Unit 1 | Industry Considerations with Phase III Clinical Trials V-1 | |
| Unit 2 | Industry Considerations with Phase III Clinical Trials V-1 | |
| Unit 3 | New Drug Application, Filing, Product Labeling II1-3 | |
| Unit 4 | New Drug Application, Filing, Product Labeling IV-4 | |
| Unit 5 | New Drug Application, Filing, Product Labeling V-5 | |
| Unit 6 | New Drug Application, Filing, Product Labeling VI-6 | |
| Chapter 7 | Quiz- Online Test | |
| Unit 1 | Quiz- Online Test |
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
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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
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