The word Pharmacovigilance is generated from two words; in that “Pharmakon” is a Greek word which means “medicinal substances” and “Vigilia” is a Latin word that means “to keep watch”.
It is most essential & important function within life science industry. PV is the use scientific methods to identify, track, record & analyze side effects or adverse effects of pharmaceutical products to ensure drug quality & safety.
Pharmacovigilance Aim
The main aim of PV is to find risks &and adverse effects of medical products. It also includes early detection of safety problems which are not identified or revealed during clinical trials. Identification of risks improves patietient’s health care and quality of pharmaceutical drugs.
Methods of Pharmacovigilance
There are following methods of PV
• Target Reporting
Collections of individual case reports are complex and heterogeneous. Not all reports are submitted to Pharmacovigilance systems by health professionals (such as doctors, dentists, nurses and pharmacists). Some are published in journals and others emerge in association with lawsuits. Direct patient reporting provides additional opportunities and challenges. The quality of reports is variable, and some important information is available only in the form of free text, and not as structured database fields. Detailed clinical review is therefore essential for effective knowledge discovery.
At the same time, clinical review constitutes the primary bottleneck: large national and international organizations collect hundreds of thousands of reports each year, every one of which cannot possibly be reviewed by the available experts. For example, the World Health Organization (WHO) Programme for International Drug Monitoring currently holds over 4.7 million reports from 94 countries with around 300,000 added each year.
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• Cohort event monitoring
To complement individual case reports, some countries have implemented cohort-event monitoring (CEM) systems for intensified follow-up of selected medicinal products. Examples include New Zealand's Intensive Medicines Monitoring Program and prescription-event monitoring in the UK. CEM encourages health professionals to report adverse events and solicits information about events that may not otherwise be reported. The cohort sizes typically range from a few thousand to tens of thousands of patients. The well-specified cohorts, together with encouragement to report all events, ideally allow incidence rates to be estimated and compared across medicinal products.. It may be especially valuable for ADR surveillance in places where there is no established Pharmacovigilance system and the collection of individual case reports is not practicable, such as for major public health programes in developing countries.
Individual case safety reports
Individual case reports (technically, ‘individual case safety reports’, even though they deal with harms) include reports to national regulatory authorities, such as the yellow card system of the Pharmacovigilance section of the UK Medicines and Healthcare products Regulatory Agency and anecdotal reports in medical journals. They communicate genuine concerns about real-life suspected ADRs. Their strength in signaling causal associations between medicinal products and adverse events depends on the skill and experience of the reporter and the documentation and characteristics of the event, including its time-course and the effect of withdrawing and/or reintroducing the suspected medication
Clinical review of case reports
Collections of individual case reports are complex and heterogeneous. Not all reports are submitted to Pharmacovigilance systems by health professionals (such as doctors, dentists, nurses and pharmacists). Some are published in journals and others emerge in association with lawsuits. Direct patient reporting provides additional opportunities and challenges. The quality of reports is variable, and some important information is available only in the form of free text, and not as structured database fields. Detailed clinical review is therefore essential for effective knowledge discovery.

Role of Pharmacovigilance in Drug Development
In drug development Pharmacovigilance possesses very crucial role, an operational overview of PV begins with safety information gathered from various sources such as clinical trials data, spontaneous reports, intensified ADR reporting literature searches, and safety call centers each of which has potential to create an individual case. Role of Pharmacovigilance in drug development phase is listed below.

1. In Drug discovery
2. In Drug Development
3. In Regulatory Review
4. In Commercialization and marketing
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