Safety and efficacy are mostly the two things to be concerned around the usage of a drug product and, we might contemplate if we have anyone monitoring that? Well yes, its Pharmacovigilance. Pharmacovigilance is the science and the actions related to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. In today’s market, we have a myriad of medicine brands with different ingredients.
Pharmacovigilance deeply focuses on adverse drug reactions like any untoward medical occurrence to a patient or during a clinical trial which is fatal or threat to life including lack of efficacy. Its main role is to detect which adverse events cross the line of a drug’s efficacy. Pharmacovigilance evolved in 1960 after a devastating drug called thalidomidecame to light. It had been promoted as a mild sleeping pill, which became responsible for the deformity of more than 20,000 infants.
Need for Pharmacovigilance?
When a new medicine/drug product is released in the market there is a lot of anxiousness about the safety of the product. Pharmacovigilance primarily identifies the hazards related with pharmaceutical products and therefore aims in minimizing the risk of any harm that may come to patients.It also oversees inaccurate or incompleteness in medication leading to overdose or after a drug abuse. It has shown its purpose on various levels. Substandard medicines, case reports of chronic/acute poisoning, vaccines are some of them. Pharmacovigilance is questionably the most essential role within a life science company. The mission of pharmacovigilance is to ensure drug safety.
Career in Pharmacovigilance
A patient’s safety has always been of prime importance in this industry and pharmacovigilance plays a significantly critical role in it. Pharmacovigilance plays a vital role in the inventive and development of a drug product and hence a career in this field always has a tremendous scope, today and in the future. Pharmacovigilance can be branched out into many areas. Some of them are;
- Qualified Person for Pharmacovigilance (QPPV’s): QPPV’s are considered as the subject matter experts. Their jobs concern with the authorizing of the marketed drugs. Their expertise is utilized on various different levels and are of high importance.
- Risk Management: Professionals mainly focus here on surveillance and signal detection. They go about analysing the risk involved derived from various inner levels. Pharmacovigilance scientist and drug safety physician are two of the roles within.
- Operations: This is the area where many of the drug safety jobs start off with their career. They collect and record the information on clinical trials apart from gathering reports on adverse events.
Many leading pharmaceutical companies today are looking for drug safety professionals to be a part of their industry and help in making a contribution with their efficient skills to this industry. There are many courses offered in this field. The James Lind institute hosts a wide range of professional course for one to excel and make a mark in the pharmaceutical industry.
The Professional Diploma in Pharmacovigilance and Pharmacoepidemiology is one of the courses that will provide the basis in pharmacovigilance principles and operations. The syllabus is completely relevant for students who want to see a career in the pharmacovigilance sector. Each student is allocated with a senior pharmacovigilance professional mentor who would guide all along the course providing all the practical knowledge required to face the industry. Once the student enrolls into this program she/he is expected to complete the course within 4-6 months however the course is self-paced with the maximum duration of 18 months.
To know more about this program and how you can build a career in pharmacovigilance please visit the following link: