Reasons Why Should Always Consider Pharmacovigilance Consulting

If you are a drug manufacturer, you have a responsibility to ensure the drug's efficacy and safety. In other words, you have to find out whether the drug works and if it's safe. You need to continuously collect and analyze data to help in preventing adverse effects of therapies and drugs. However, do you have what it takes to monitor and identify hazards associated with your pharmaceutical products? If you don't have the right technical team and infrastructure, you need to consider pharmacovigilance consulting.

Why is Pharmacovigilance Vital?

If you run a pharmaceutical company, a patient's safety should always come first. Thus, pharmacovigilance should be among the most essential functions of your organization. As you know, drug manufacturing is highly regulated. Most of the regulations in this sector focus on two main things:

  • The patient's safety
  • The benefits that a drug has to the user

In this context, you have to ensure that the patient's wellbeing and safety are safeguarded throughout the whole drug development lifecycle. The principal goal is to warrant that the final pharmaceutical product does not pose any health risk to the user. You need to continuously collect and report data about adverse events and adverse reactions.

Why Should You Engage a Pharmacovigilance Consulting Company?

Pharmacovigilance should always be performed by a qualified person for pharmacovigilance (QPPV). These persons are considered experts in adverse events coding, seriousness determination, writing case safety reports, and clinical trial reporting.

Hiring these professionals on a full-time basis and establishing the right infrastructure is expensive. Thus, outsourcing all aspects of pharmacovigilance becomes the most viable option.

Today, outsourcing has gained overwhelming popularity in the United States and beyond. It is estimated that about 70% of firms outsource essential and non-essential business functions to reduce costs.

Similarly, you should also consider pharmacovigilance consulting and enjoy the following benefits:

  • Expert skills in pharmacovigilance
  • Objectivity
  • Substantial cost savings

A drug safety expert does not replace your drug manufacturing team. Instead, they work collaboratively with them and assist with:

  • Preparing marketed and clinical case safety reports
  • Developing aggregate safety reports
  • Conducting continuous marketed and clinical signal analysis and detection
  • Providing scientific literature surveillance

In this context, pharmacovigilance consulting ensures that you have placed your risk management and epidemiology activities in experienced hands. You can always engage a consultant for the entire pharmacovigilance process or get an urgent solution to a specific problem.

The Bottom Line

Patient safety should always be your priority as a drug manufacturer. Thus, you need to continuously collect and analyze data about your clinical and marketed products. If you don't have the tools or expertise, you should engage a pharmacovigilance consulting company.