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Drug Safety Monitoring

Drug Safety

Drug Safety Monitoring

Why is drug safety monitoring important?

Adverse Drug Reactions (ADRs) are among the top ten leading causes of death in most of the countries. An adverse drug reaction could be any unintended reaction in patient’s body which occurs as a result of administration of drug. Drug safety monitoring is a risk mitigation exercise in which the ADRs caused by therapeutic drugs, biologicals or devices can explored, prevented or minimized.

It is the process of identifying expected and unexpected adverse reactions resulting from the use of medicines in the post-marketing phase. Pharmacovigilance is an umbrella term used to describe the process of drug safety monitoring and can be defined as the branch of science that carries out activities related to detection, assessment, understanding and prevention of adverse drug reactions. It primarily aims at rational use of medicines to assure safety of patients. Thus pharmacovigilance has become a key aspect of effective clinical practice in many countries.

Scope of pharmacovigilance

Most of the pharmaceutical and clinical research companies are carrying out pharmacovigilance activities to monitor and report adverse drug reactions of their products. The unknown or poorly understood adverse reactions when reported to concerned regulatory authorities on a regular basis will be analysed and effectively communicated for further interpretation. This helps healthcare professional to understand and analyse the risks associated with administration of the medicine they prescribe and amend the recommendations on their use accordingly. This process results in the accumulation of an immense volume of data in the form of ADR reports. Now-a-days, these activities are being outsourced to multinational companies resulting in the generation of various job opportunities across various life science companies including pharmaceutical and biotechnology companies, Contract Research Organizations (CROs), BPOs, consultancies and generic companies to name a few. Apart from local drug companies, many global players namely Quintiles, GlaxoSmithKline, Pfizer etc. have set up their own pharmacovigilance centres across the world.

Online courses in Pharmacovigilance at James Lind Institute

In order to make sure that the process of drug safety monitoring is in accordance with the regulatory requirements of respective country, industry is in need of trained manpower. Various online training programs on pharmacovigilance are available at James Lind Institute in which participants are trained in the fields of drug development, clinical research processes, clinical trial management, drug regulatory laws and pharmacovigilance systems. Pharmacovigilance professionals may hold a position of drug safety associate, drug safety specialist or drug safety physician, QPPV in an organization.
The programs available in this category are designed by industry experts and tailored to meet end-to-end needs of the industry. The pharmacovigilance courses at James Lind Institute are as follows:
Advanced PG Diploma in Clinical Research and Pharmacovigilance
Advanced PG Diploma in Pharmacovigilance and Regulatory Affairs
Advanced PG Diploma in Pharmacovigilance and Medical Writing
Advanced PG Diploma in Pharmacovigilance and Quality Assurance
Advanced PG Diploma in Pharmacovigilance and Data Management
Professional Diploma in Pharmacovigilance and Pharmacoepidemiology
These programs are suitable for fresh graduates as well as working professionals with a degree in medicine, dentistry, pharmaceutical sciences, nursing, biostatistics, bioinformatics, Life sciences, chemistry, and all allied health sciences. Technologically advanced e-campus of JLI acts as a contemporary substitute to standard classroom programs. In addition, JLI offers personalized classroom activities through an Online Campus Tutoring Centre, mock drills, tutoring and freelancing opportunities.
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