Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research.
PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health.

The Drug Safety Officer (DSO) is responsible for the review of all study-related documents and the detailed safety review of all incoming CRFs within 24 hours after receipt (or at least on the next working day in the case of weekends). Previously not recognized or not appropriately reported Serious Adverse Events or Unexpected Adverse Events must be notified to the sponsor within 24 hours and documented on an initial SAE report form. If data is incomplete or inconsistent, the DSO may contact the investigator directly for clarification of those issues and document this in an SAE follow-up report.

Safety reporting

Safety reporting is an important component of pharmacovigilance. According to schedule Y, periodic safety update reports (PSURs) are submitted once in every six months for two years and subsequently, once in every two years. PSURs include current worldwide marketing status, update of actions taken for safety reason, etc.