The Diploma in Pharmacovigilance offered by PharmaExa is a specialized 3-month online certification program designed to provide learners with a thorough understanding of drug safety monitoring and adverse event reporting throughout the life cycle of pharmaceutical products. This program focuses on key areas such as the principles of pharmacovigilance, global regulatory requirements (like WHO, USFDA, EMA), case processing, MedDRA coding, signal detection, risk management, and safety databases. It is ideally suited for graduates or final-year students in Pharmacy, Medicine, Nursing, Biotechnology, or other life sciences, as well as professionals working in clinical research or regulatory fields seeking to upskill in drug safety. The course is accredited by IACCRE and includes an online verifiable certificate, lifetime access to expert-developed study materials, and dedicated placement support. By completing this diploma, candidates become eligible for roles such as Drug Safety Associate, PV Officer, or Case Processor in pharmaceutical companies, Contract Research Organizations (CROs), and regulatory bodies—making it a career-defining credential for those aspiring to work in the field of pharmacovigilance.
Pharmacovigilance is the identification, evaluation, awareness and prevention of adverse reactions, especially the long-term and short-term side effects of therapeutic drugs, devices and biologics.
There are common guidelines and principles that regulate the globalization of the health and pharmaceutical industries. Therefore, the implementation of a global systemic structure for pharmacovigilance requires a large number of trained professionals in this area.
The online course Professional Certification in Pharmacovigilance (PCPhV) allows learners to take an in-depth look at the relevant global standards, AE reporting methods and procedures, findings and evaluations, etc.
For more details, you can see the Curriculum Tab. This course would provide you with the necessary knowledge and thus enable you to excel on your career as a Drug Safety Associate or Pharmacovigilance Associate with Pharmaceuticals / Biotech Cos., Research Cos., IT firms, CROs, Hospitals, PV Centers, SMOs, KPOs, etc.
Module: 1 Introduction to pharmacovigilance
Unit 1 Introduction to Pharmacoviginalce
Unit 2 The history of PV
Unit 3 The Burden Of Adrs And The Need For Pv
Unit 4 Aims Of Pv
Unit 5 The Scope Of Pv Part 1,2,3
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Module:2 Signal detection and causality assessment
Unit 1 What Is A Signal, When Does Signal Detection Start & Why Do We Need Signal Detection
Unit 2 Where Can We Find Signals, What Triggers A Signal, How Do We Assess A Signal
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Module 3: Statistical reasoning and algorithms in pharmacovigilance
Unit 1 Statistical Reasoning And Algorithms In Pv, Dis-proportionality, Relative Reporting Ratio (Rr)
Unit 2 Random Variability, Decision Rules,Aspects Of Strength Of Evidence, A Cautionary Note
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Module 4: Medical Dictionary for Drug Regulatory Activities (MedDRA)
Unit 1 Medical Dictionary for Drug Regulatory Activities (MedDRA)
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Module 5: Individual Case Safety Reports (Icsrs)
Unit 1 Individual Case Safety Reports (Icsrs)
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Module 6: Pharmacovigilance Aggregate report
Unit 1 PV-1.Development Safety Update Report (Dsur)&Benefit-Risk Evaluation Reports (Pbrers)
Unit 2 Aggregate report writing in PV- 2. Dsur And Pbrer(Section1 To Section-5)
Unit 3 Aggregate report writing in PV- 3 Dsur And Pbrer(Section 6 & Section-7)
Unit 4 Aggregate report writing in PV- 4. Dsur And Pbrer( Section 8 To Section-15)
Unit 5 Aggregate report writing in PV- 5. Dsur And Pbrer( Section 16 To 18)
Unit 6 Aggregate report writing in PV-6. Dsur And Pbrer (Section -19)
Unit 7 Aggregate report writing in PV-7. Practice Dsur And Pbrer
Unit 8 Aggregate report writing in PV-8. Periodic Adverse Drug Experience Report (Pader)
Unit 9 Aggregate report writing in PV-9. Risk Management Plan(Rmp)
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Module 7: Periodic safety update report (PSUR)
Unit 1 Periodic safety update report (PSUR)
Unit 2 Dsur Vs Psur in Pharmacovigilance
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Module 8: Online Examination
Unit 1 Quiz
You can also view our FAQs page for further queries.
Student 3200
Length: 4 weeks
Timings: Self Paced
Language: English
Effort: 55 hrs. approx
Skill Level: All
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