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What is Pharmacovigilance (PV)?

Pharmacovigilance deals with functions related to assessing drugs, detecting them for any harmful substances used in their production or the adverse effects that the drugs cause on human health. It ensures that the drugs produced by the pharmaceutical company are safe to use and do not show any adverse effects. Its scope is quite wide and covers all the pharmaceutical products. In the entire process of drug development, pharmacovigilance plays an important role by checking the safety of the new drug that is being developed. Moreover, it ensures adherence to all national and international laws, regulations, and guidelines throughout the trial.

What is an Adverse Event?

The major motive of any medicine or vaccine produce a positive impact on human health. However, at times the drug doesn’t go well with the person’s body and creates a harmful impact. This situation is referred to as adverse impact. The severity of such incidences varies greatly and in the worst case, it may even lead to the death of the person. In order to prevent such incidents, the pharmacovigilance team accurately monitors the data and reports adverse events.

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Why is Pharmacovigilance Important?

The primary importance of pharmacovigilance is that it helps in assuring the quality and safety of any medicine. In accordance with national and international rules, pharmacovigilance professionals help in ensuring that the drugs made available for public use are safe. Apart from it, they play an essential role in the decision-making process. The data collected helps policymakers in making informed decisions about drug approvals, withdrawals, or restrictions from the market. These duties help in building the trust of the public as well as healthcare providers like doctors. The efficacy and safety of the drug help in building the credibility of the manufacturing company.

What are the Main Areas of Pharmacovigilance?

Pharmacovigilance works in various departments throughout the trial process. However, their work can be segregated in four major areas. These four main areas of pharmacovigilance are:

- Operations

It includes collecting data and recording important information during the development of clinical trials. It also includes reporting on adverse events by gathering information from doctors and patients after the drug has entered the market. This is the primary function of the Pharmacovigilance team and they are helped by other professionals like clinical data managers, associates, and data analysts.

- Surveillance

This is the key role of every Pharmacovigilance professional while conducting the trial. The major focus of these professionals is on assessing and managing risk and detecting potential issues regarding drugs. They analyze the data collected and create reports. This helps in evaluating the safety and effectiveness of drugs. Surveillance helps researchers in knowing the impacts of the medicine that is being produced and make changes accordingly.

- Systems

This department builds and maintains a robust system to store and provide access to safety data. It is a challenging and crucial aspect of drug safety, as it needs to comply with changing regulations and requirements. Also, they should be careful that the data generated is not tampered with by anyone. This helps in maintaining the authenticity and transparency of the vital information derived from the trial.

- Qualified Person for Pharmacovigilance (QPPV)

These experts mainly deal with drugs already in the market or about to be authorized. They are highly experienced and provide strategic advice on adhering to regulations across the nation. Thus, they have adequate knowledge of the safety rules that are prevailing in the country as well as internationally. They are well aware of the contemporary trends. In a way, they perform one of the significant roles in addressing public issues.

What will be the Role of Pharmacovigilance in the Future?

Pharmacovigilance is an inseparable part of the drug development process. The pharma industry is growing at a rate of 10% every year. India is becoming one of the largest pharma producers globally. The number of clinical trials conducted every year is growing and the demand for pharmacovigilance is also on the rise. The essential role played by the pharmacovigilance department helps in developing trust in the product and improve its safety. Thus, we can say that future in pharmacovigilance will witness even more growth and play a crucial role in drug safety and clinical research.