The Medical Representative at the Heart of the Pharmacovigilance System

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In the pharmaceutical industry, the role of the medical representative is not limited to presenting scientific and regulatory data related to the drug to healthcare professionals. The medical representative embodies a key vector of safety, transparency, and field monitoring, positioned at the crossroads of regulatory requirements and medical needs.

An Essential Mission with Healthcare Professionals

The medical representative is the spokesperson of the laboratory in the field. As such, they must:

  •  Disseminate pharmacovigilance information transparently.
  •  Systematically inform healthcare professionals in the event of significant events, such as changes to the SmPC or the emergence of new data concerning adverse effects.
  •  Present and propose the provision of risk minimization documents as outlined in Risk Management Plans (RMPs).

In practice, this involves staying up to date, mastering key messages, and being able to respond accurately to healthcare professionals' questions.


A Crucial Mission for the Laboratory

In the field, the medical representative must ensure that healthcare professionals have access to the latest reliable and validated information about the medications they present. Specifically, they must:

  •  Collect pharmacovigilance data, product complaints, and medical information requests from healthcare professionals and promptly forward them to the company, particularly to the pharmacovigilance manager or the responsible pharmacist.
  • Report without delay any information regarding the use of medications, particularly concerning adverse effects and off-label uses.
  • Contribute to the improvement of products and therapies by collecting observations on the use of products in real-world settings.

By acting as a liaison between healthcare professionals and the laboratory they represent, the medical representative is thus a key player in the management of drug safety.

Training in Pharmacovigilance: A Key Step in the Role of a Medical Representative

For medical representatives, good pharmacovigilance practices involve a thorough understanding of the regulatory framework and the right reflexes to adopt in specific situations.

For trainers in the pharmaceutical industry, it is crucial to effectively prepare medical representatives, the real field sentinels, who play a central role in the pharmacovigilance system.

Phosphore Santé’s Solution

Committed to supporting medical representatives in all their missions and to promoting best practices in pharmacovigilance, Phosphore Santé has developed a regulatory module dedicated to pharmacovigilance, designed to be impactful and enjoyable to navigate.

Interested in a demo? Contact us!

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