5 Pharmacovigilance Issues A Consultant Wants On Your Checklist

Pharmacovigilance is one of the most important jobs at any company creating drugs, cocktails, and treatments. It's important to develop a detailed checklist for every project, and here are 5 items a pharmacovigilance consulting company will want you to have on yours.

Reporting of Serious Adverse Effects

According to the FDA, serious adverse effects must be reported within 15 days of your receiving the notification that they're a concern. It's important to have a process in place to get the notice to the right party as soon as possible, note when the clock starts, and produce the necessary reports for both internal and external consumption. A pharmacovigilance consulting professional can help you get this process in place and train team members in using it.

Data Exchange

It's common for companies to engage in data exchanges, but the government agreements are often thin or non-existent. Especially when working with parties overseas, it's critical that data exchanges happen rapidly. If a partner in Europe, for example, changes the labeling for the toxicity risks associated with a drug, you want to get that information as quickly as possible.

Putting Safety Ahead of Efficacy

Folks who've invested years of effort in proving the efficacy of a drug can suffer from tunnel vision. It's important, however, to understand how and why safety has to come before efficacy. Fortunately, a pharmacovigilance consulting company can provide an independent view of the problem. They can set safety protocols up in a way that will ensure processes and reports transmit the necessary information for decision-makers to change labeling, notify the FDA, or event halt testing and production.

Integrating Computerized Systems

One of the most important aspects of pharmacovigilance is removing as much potential bias as possible. Management systems for handling clinical trials, data, coding, and product performance are all regularly used for this job. A consultant can help you select software and hardware, tie them into your databases, and prepare your staff members for utilizing them.

Not only will this sort of automation reduce human-induced bias, but it will also streamline a number of processes. Safety information will emerge faster, and you'll also be able to get products to market sooner.

Standardizing Reporting

Producing consistent reports is important, and standardization can make a big difference. Team members need to know what the formatting for reports will be and who to send reports to. Also, they should be provided instruction for getting them right.

To learn more information reach out to a pharmacovigilance consulting company near you.