JUMP TO CONTENT

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

Posting date: 17/02/2023
Author: Inside ICON

Clinical research is the backbone of the medical industry. Without it, it would be impossible for drugs and medical treatments to prove compliance and become approved for market sale. Drug safety plays a huge role in these trials.

In fact, the recent Covid-19 pandemic has put a spotlight on drug safety, meaning pharmacovigilance is now arguably the most scrutinised aspect of clinical research. Now more than ever, it’s essential that we understand the purpose of the pharmacovigilance team in clinical research.

1: Identify adverse drug effects

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.

2: Protect consumers

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.

3: Protect businesses

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.

4: Drive future R&D decisions

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.

Move your pharmacovigilance career forward with ICON

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.

List #1

Related jobs at ICON

Senior Pharmacovigilance Reporting Associate

Salary

Location

India, Chennai

Location

Chennai

Trivandrum

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I

Reference

JR116190

Expiry date

01/01/0001

Archana Bakkiyarajan Read more Shortlist Save this role
Senior Medical Coding Specialist

Salary

Location

Manila

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Manila

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

As a Senior Medical Coding Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligenge. You will be partnering with a glo

Reference

2024-110426

Expiry date

01/01/0001

Sitti Lim

Author

Sitti Lim
Sitti Lim

Author

Sitti Lim
Read more Shortlist Save this role
Clinical Research Physician

Salary

Location

Brazil, Sao Paulo

Location

Sao Paulo

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Physician

Job Type

Permanent

Description

Clinical Research Physician - Sao Paulo - Homebased roleICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research

Reference

JR117027

Expiry date

01/01/0001

Elizabeth Davies Read more Shortlist Save this role
Pharmacovigilance Associate

Salary

Location

Japan, Tokyo

Location

Tokyo

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug Safety

Job Type

Permanent

Description

ファーマコビジランス部門・PMSチームにて、安全性個別症例評価プ ロセス一連の業務(入力、評価、当局報告書作成等)の実施、業務管 理、またご経験に応じて3~10名程度のメンバーのリード業務および 関連付随業務を担当いただきます。    【その他の業務】 ・安全性データベース及び業務に必要なシステムの運用を理解し、必 要に応じマニュアルの作成等を担当する ・GVP、SOP を遵守した安全性個別症例評

Reference

JR116290

Expiry date

01/01/0001

Daiki Matsumoto Read more Shortlist Save this role
View all
List #1

Related stories

Tablet medication
Navigating the Drug Approval Process

Teaser label

Industry

Content type

Blogs

Publish date

05/29/2024

Summary

The journey of a new drug from its inception in the laboratory to its eventual approval for public use is a complex and highly regulated process. In this comprehensive blog, we cover the numerous l

Teaser label

Explore the complex journey of new drugs from lab to market in this blog.

Read more
Headshot of Deepak, the author of this blog
Day in the life of a Clinical Data Management Project Manager

Teaser label

Our People

Content type

Blogs

Publish date

05/20/2024

Summary

Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o

Teaser label

Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

Read more
Image depicting a career path
Resume Gaps: Showcasing Career Breaks Positively

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Overcoming Resume Gaps In an ideal world, resumes would neatly showcase an uninterrupted career progression. However, In today's dynamic job market, it's not uncommon for professionals to encoun

Teaser label

Periods of unemployment don't have to be a red flag. Learn proven strategies for addressing resume gaps.

Read more
View all
List #1

Recently viewed jobs

Browse popular job categories below or search all jobs above