Drug Safety Physician Course
OR
Prepared by Docthub Courses Team ∣
Last updated on 17 Jul 2025
Overview
Designed for medical graduates, this training addresses safety evaluation and regulatory reporting of medicines post‑marketing. The training offered addresses major components such as pharmacovigilance, assessment of causality, risk communication, and management of ADRs. The subject area includes a comprehensive overview of safety legislation, global regulatory standards and practices, and integration of safety databases. Complex clinical evaluations and decision making are further solidified through case discussions. Other topics include signal detection, safety surveillance, periodic safety update reporting (PSUR), and risk management planning. Hands-on experience is given through internships in the pharmacovigilance departments of pharmaceutical companies or hospitals. Patient safety, as it relates to ethical and legal matters, will also receive emphasis in course work. Safety committees, submissions to regulatory agencies, and clinical safety monitoring activities conducted post-approval are the spaces into which trained attendants will walk. It sets doctors on course toward employment as drug safety assessors, medical reviewers, and regulatory consultants. When they complete their training, they can either lead a pharmacovigilance team or opt for higher-level clinical safety positions.
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Qualifications
MBBS
Related Specialty
Clinical Pharmacology
Drug Regulatory Affairs
Clinical Pharmacy
Drug Design
Drug Discovery