Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Our 3-year Pharmacovigilance program at Viast equips students with the critical skills needed to ensure drug safety and efficacy, safeguarding public health. The curriculum covers pharmacovigilance principles, regulatory guidelines, risk management, and the use of modern tools and databases for monitoring drug safety. Through practical training and industry internships, students gain hands-on experience in real-world pharmacovigilance activities.

Duration: 3 years

Eligibility: 10+2 with Science stream

Career Prospects: Pharmacovigilance Specialist, Drug Safety Officer, Regulatory Affairs Manager, Clinical Research Associate, Medical Review Officer.

Course Structure:

Introduction to Pharmacovigilance:

•    Basics of pharmacovigilance
•    History and evolution of drug safety
•    Regulatory framework and guidelines (ICH, WHO, FDA, EMA)

Drug Safety Monitoring and Reporting:

•    Adverse drug reaction (ADR) reporting systems
•    Signal detection and management
•    Case processing and narrative writing

Risk Management and Assessment:

•    Risk-benefit analysis
•    Risk management plans (RMP)
•    Pharmacovigilance system master file (PSMF)

Pharmacoepidemiology and Biostatistics:

•    Study designs in pharmacoepidemiology
•    Data analysis and interpretation
•    Statistical methods in drug safety

Regulatory Affairs and Compliance:

•    Regulatory submissions and documentation
•    Good Pharmacovigilance Practices (GVP)
•    Compliance with global regulatory requirements

Practical Training and Industry Exposure:

•    Internships with pharmaceutical companies and regulatory agencies
•    Hands-on training with pharmacovigilance databases (e.g., VigiBase, ARISg)
•    Case studies and real-world projects

Capstone Project:

•    Independent research project in pharmacovigilance
•    Collaboration with industry mentors
•    Presentation and defense of research findings