Professional Diploma in Drug Safety & Pharmacovigilance

Program Description

Program Highlights • 6 In-depth Training Courses supervised by experts. • Hands-on practice on PV databases, QMS, and documentation. • Real-world case studies covering PV operations, signal detection, and safety reporting. Program Structure The diploma program is structured into two modules across two semesters, with each semester comprising 3 core courses.

Learning Outcomes

• Learning Outcomes By the end of the program, you will: • Apply core PV principles and develop Pharmacovigilance System Master Files (PSMF). • Formulate strategic Pharmacovigilance Plans and Risk Management Plans (RMPs). • Execute signal detection, interpret medical aspects of ADRs, and manage adverse reaction reporting. • Master MedDRA coding and write case narratives for ICSR processing. • Prepare comprehensive PBRERs, conduct risk-benefit assessments, and develop risk communication plans. • Analyze drug safety data using pharmaco-epidemiology and biostatistics.