What is the purpose of a pharmacovigilance team in clinical research?

The primary purpose of the pharmacovigilance team is to undertake thorough drug testing to identify and better understand the risks associated with taking the studied drug. During the drug development stage, the risk of negative side effects is always present. This is simply the nature of clinical research. So, the pharmacovigilance team's role isn’t just to identify whether risks are present, but also to help the clinical research team understand whether those risks outweigh the benefits.

For example, Minoxidil, a topical treatment for hair loss has a relatively long list of ‘rare’ and ‘less common’ side effects. These include potential inflammation at the root of hairs, acne, swelling and a burning sensation. However, as most side effects are rare and often not severe, this makes Minoxidil a widely used option for those suffering from a loss of hair.

Although pharmacovigilance teams typically conduct their studies during the clinical trial stages, they may also undertake post-market drug safety surveillance. This is because it is typically difficult to understand the full scope of potential risks when used over a short-to-mid-term trial and with a select number of trial participants.

Consumer protection is a key focus of the pharmacovigilance team. Any negative outcomes discovered during their trials will result in a much deeper study, to understand the full extent of those adverse effects. Occasionally this will lead to drugs being deemed unsuitable for use by consumers. On other occasions, it will simply allow drug manufacturers and medical professionals to better explain to consumers the trade-offs associated with using that drug.

Again, there is a balance to be found between the benefits and negatives of treatment. The side effects of a drug created to treat a minor ailment may be deemed unmarketable, whereas a drug for treating a life-threatening illness with the same side effects would be deemed worthy of release.

For example, the use of chemotherapy for cancer treatment is considered a worthwhile option in most cases, even though the side effects can be considered severe. In contrast, if the same side effects were present for a mild pain relief medication, it would be considered unviable.

As well as protecting consumers against the negative impacts of treatment, pharmacovigilance also offers drug and treatment manufacturing businesses protection. It helps businesses better understand the risks involved with the solutions they are creating - ensuring that they can properly communicate these risks or mitigate them in some way, helping to protect them against potential litigation.

Without the adoption of a pharmacovigilance team within clinical research, it’s more likely that a lack of due diligence is found on the part of the manufacturer. This can leave them vulnerable should any issues with their treatments occur. It also ensures that they are compliant with the regulations surrounding their treatment options.

One of the biggest benefits of utilising a pharmacovigilance team in clinical research is how businesses can drive their findings into future R&D decision-making. Identifying potential risks in treatments offers businesses a clear path of focus. This can either be done by conducting R&D into mitigating these risks or by eliminating them from treatment altogether.

Alternatively, businesses may opt to use R&D to create further drugs that can be used to support the reduction of side effects. For example, it is common for some drug treatments to be taken alongside other drugs to help the patient better deal with side effects.

There’s no denying that the pharmacovigilance team play a pivotal role in clinical research. Without them, not only would it be impossible for businesses to achieve compliance, but it will also leave them vulnerable to litigation. These teams also play a crucial part in ensuring that consumers are better informed of potential side effects, making it easier to manage their treatments.

If you are looking to start or progress your career in clinical research a role in a pharmacovigilance team may be perfect for you. Check out our latest pharmacovigilance opportunities to find your next role.