Introduction:
Pharmacovigilance & ADR Reporting focuses on the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and other drug-related problems. It plays a crucial role in ensuring medication safety throughout a drug’s lifecycle, from clinical development to post-marketing surveillance. Pharmacovigilance systems help healthcare professionals and regulatory authorities identify potential safety signals, evaluate risks, and ensure the safe and rational use of medicines in clinical practice.

Scope:
The scope of Pharmacovigilance & ADR Reporting includes monitoring drug safety, identifying adverse drug reactions, signal detection, risk assessment, and regulatory reporting requirements. It also covers the structure of pharmacovigilance systems, spontaneous reporting programs, global safety databases, causality assessment methods, and regulatory frameworks used to maintain drug safety in healthcare systems.

Objectives:

• To understand the principles and importance of pharmacovigilance in ensuring drug safety.
• To develop knowledge of adverse drug reaction identification and reporting procedures.
• To understand causality assessment, signal detection, and risk evaluation methods.
• To familiarize learners with regulatory guidelines and pharmacovigilance reporting systems.
• To prepare learners for professional roles related to drug safety monitoring and pharmacovigilance operations.

Who can enroll:
This program is suitable for pharmacy students including B.Pharm, M.Pharm, and Pharm.D, life science graduates, clinical research professionals, and healthcare practitioners involved in medication safety monitoring. It is also beneficial for individuals seeking to build foundational knowledge and career opportunities in pharmacovigilance and drug safety reporting.

Study materials include:

• Expert-Led Videos – Demonstrating immunization practices, vaccine handling, and administration techniques
• Portable Document Format Materials – Covering immunization guidelines, schedules, and safety checklists
• Self-Paced Learning Modules – Supporting continuous professional development and real-world practice integration