Certificate in Pharmacovigilance Syllabus 2025: Subjects, Specializations, and Semester-wise Syllabus

Syllabus for Certificate in Pharmacovigilance Course

The Certificate in Pharmacovigilance course syllabus encompasses a comprehensive study of the critical aspects of drug safety and surveillance. The program typically begins with an introduction to pharmacovigilance principles and regulatory frameworks, providing students with a solid foundation. It then delves into the methodologies and techniques for collecting, assessing, and managing adverse drug reactions (ADRs), including signal detection and risk assessment. Furthermore, the curriculum covers the role of pharmaceutical companies, regulatory authorities, and healthcare professionals in pharmacovigilance, emphasizing the importance of compliance with global safety standards. The course also explores the use of databases and tools for data analysis and pharmacovigilance reporting. Ethical considerations, communication strategies, and crisis management in the context of pharmacovigilance are other key topics addressed. Throughout the program, students engage in case studies, practical exercises, and discussions to gain hands-on experience and a deeper understanding of real-world pharmacovigilance challenges. By the end of this course, participants will be well-equipped with the knowledge and skills necessary to ensure the safe and effective use of pharmaceutical products in the healthcare industry while adhering to regulatory guidelines.

Syllabus of Certificate in Pharmacovigilance

S.No	Subjects
1	Introduction to Pharmacology, Clinical Trials, and Pharmacovigilance
2	Adverse Drug Reactions and Safety Reports
3	Methodologies in Pharmacovigilance
4	Seriousness & Expectedness & Causality Assessment Criteria
5	Aggregate Safety Reports
6	Pharmacovigilance Regulations in Various Countries
7	Pharmacovigilance Programme in India (PVPI)
8	Signal Detection and Data Mining
9	Pharmacovigilance of Herbal Drugs & Medical Devices
10	Pharmacovigilance Compliance and Inspections