Career options & Prospects in Pharmacovigilance in Clinical Research

Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry.

What is Pharmacovigilance (PV)?

Pharmacovigilance is nothing but a drug safety. It is a scientific method of evaluating, understanding, monitoring and preventing adverse side effect of drug in a medical trial. 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.

Role of Pharmacovigilance in Drug Development

The process of drug discovery and development is a long-term, competitive, expensive and complicated process. Bringing the drugs from the bench to the market, that is, from screening and identification of the drug as a compound to

its introduction to the market, takes several years of efforts. The process of discovering and developing a new drug involves an intricate interaction between investors, industry, academia, patent laws, regulatory authorities, marketing and the necessity to balance confidentiality with communication. The complete process of presenting a drug to the patients involves four stages-

1. Drug discovery,

2. Drug development,

3. Regulatory review and approval,

4. Marketing

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.

• 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.

Career in Pharmacovigilance

Clinical Research is the way of advancing knowledge about health, illness and healthcare. There are various types of contemporary career options which you will get in this field. The medical industry is growing with huge rate in India and the growth will be increase ever after. Some jobs in clinical research and Pharmacovigilance are listed out below

• Head of Pharmacovigilance

• Drug Safety Physician/Directors of Drug Safety

• Pharmacovigilance/Drug Safety Product Manager

• Drug Safety Associate

• Medical Assistant

• Safety Systems Specialists

• Pharmacovigilance Trainer

Opportunities in Various Fields

After completion of training or certified course in clinical research & PV candidates are having opportunities of getting placed in following sections

• Pharmaceutical Companies

• Biotechnology company

• Clinical Data Management companies

• Pharmacovigillence Centers

• IT companies in healthcare

• Central laboratories

• Clinical CRO(Contract research Organization)

• Data management CROs(Contract research Organization)

• Packaging labeling and contract manufactures