Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines. At an ever-growing scale people are using newer and more effective drugs with various medical conditions which are being manufactured with developing scientific advances. Safety and efficacy are the two major concerns about any drug. In the recent days, significance of PV is growing and with the contemporary high-profile drug extractions by the regulatory agencies, consumers and others have become more responsive about the advantage and hazards of remedies. An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders, more importantly by the regulatory authorities. To understand PV a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. This review gives a systematic approach towards PV and the various strategies and proposals to build, maintain and implement a robust Pharmacovigilance system.

The author is a Clinical Pharmacist and Research associate keen in various regulatory affairs of the field. She has to her credit several research publications in several international journals with impact factor and hold reviewer ship in leading peer reviewed journals in the concerned forum.

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