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. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums.
The main aim of pharmacovigilance is to provide complete and clear information related to drug safety and various risks and benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in-vivo method. It enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system. Pharmacovigilance legislation gives an outlook on the rules and laws to follow in Pharmacovigilance practice. The Role of pharma industries in the improvement of pharmacovigilance system is very crucial to maintain the safety data, Detection and Evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines.
The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically.
Hence, 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.
We provide Pharma Regulatory Affairs course in two levels as Professional Designation for undergraduate students and Advance PG Program for Graduated Students. The details of the courses are as below:
As per the associated pharmacovigilance experts perspective Pharmacovigilance means keeping eye on the drugs in pharma market and their safety profile. Pharmacovigilance was novel field in 2006-2007 in India and those who entered this field at that time are earning handsomely. But nowadays, it is becoming more saturated.
There are different field in pharmacovigilance like:
♦ ICSR's, Individual Case safety reports
♦ PSUR Periodic Safety update reports
♦ Signal detection
♦ Risk Management
♦ Medical coding
♦ Medical writing
♦ Literature search
PSURs are new field slowly gaining popularity and also monetary wise PSUR skilled person are paid more. Same scenario is with Signal detection and Risk Benefit Assessment. Hence pharmacovigilance field is up coming but you need to see future in which branch of pharmacovigilance your work is associated. You constantly need to be updated every year to see scope in pharmacovigilance and every branch which is upcoming. In terms of revenue, the global pharmacovigilance market is estimated to expand at a healthy CAGR of 14.2% through 2020. The global pharmacovigilance market was valued at US$ 2,759.1 Million in 2014 and is expected to reach US$ 6,104.1 Million in 2020, expanding at a CAGR of 14.2% from 2015 to 2020.