The Importance of Pharmacovigilance

What is Pharmacovigilance?

Pharmacovigilance can be defined as the science and all activities that highlight assessment, detection, prevention, and understanding of all the adverse effects that are medically related. Pharmacovigilance is all about efficacy and safety. Is a drug safe, and does it work? These are the questions that Pharmacovigilance attempts to answer.

It covers the whole aspect of the drug lifecycle. It touches every step right from preclinical development until it’s in the market. It surveys and ensures that the company producing the drug has fulfilled the fundamental function of the medicine.

What are adverse effects in medicine?

An adverse event is a reaction that a patient experiences in their body, which is caused by the drug consumed. It can also be termed as a side effect. A severe adverse effect is a life-threatening effect that can lead to:
• Incapacity
• Hospitalization
• Death
• Permanent damage

Adverse side effects should all be reported for thorough research by clinical research investigators. Even if the adverse events are only suspected, they should be reported. The significant role of Pharmacovigilance is to know the specific adverse events that are crossing the line of a drug’s safety and efficacy.

In other terms, it’s analyzing which adverse events are worth the risk to the patient’s body compared with how effective they are when handling a disease. A good example is chemotherapy. The side effects are horrible, but they are ruled acceptable as a potential cure to the patient.

What are the significant areas of Pharmacovigilance?

Pharmacovigilance is an extensive discipline. However, it can broadly be divided into four other major sub-specialisms. They include:

Operations

This is the specialism where several life science experts are extremely interested in drug safety jobs, which mark the start of their careers. Normal jobs within drug efficacy and safety operations entail:
• Drug safety manager
• Case processor
• Drug safety associate
• Team leader
• Director

These professionals are responsible for overseeing the collection and recording of information in the preclinical development and all the clinical trials. Additionally, they gather real-world evidence of side effects that have been reported by patients and doctors in the post-market.

Surveillance

Professionals that have their focus on surveillance always tend to look towards signal detection and risk management jobs. This also entails conducting an analysis of the information collected. Professionals in this bracket can hold many titles.

Systems

This division is responsible for building and overseeing the ongoing development of an entirely strong and innovative system. Additionally, they are entrusted with the responsibility of allowing access and housing various forms of safety data.

The data in this context is collected by professionals working in various focused roles. But, the information is accessed by all. This division aims to continually alter and improve the requirements and regulations for the business with an unwavering focus on drug safety.

Qualified Person for Pharmacovigilance

The QPPV jobs are majored in marketed and all yet to be authorized drugs. This is a role that is considered a subject of the experts. The expertise of professionals is required in this division and even across other disciplines of the business.

Why is Pharmacovigilance crucial?

This is arguably the essential function of a life science organization. For a company to develop, make, and commercialize a drug, they have to follow specific regulations. Many of the regulations are focused on the benefit and safety of the patient. The following are the roles of Pharmacovigilance.

Patient safety

It ensures that a patient’s wellbeing and safety is secure in the whole drug development cycle. This also includes when the drug is being distributed in the market.

Authority and power

This means that senior professionals within the drug safety team can take responsibility and authorize that a particular drug’s development be halted immediately. Also, they can order pulling out of an approved drug in the market.

Keeping the drug moving

Drug safety also ensures that the pharmaceutical industry is in constant motion. If the nature of the drug is okay, they ensure that it’s being developed and sold in the market. This division is responsible for adding a lot of value to the pharmaceutical business.

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