Global pharmacovigilance enables Sanofi to monitor the benefit-risk of its therapies, to better serve our prescribers and safeguard our patients.
In the Your Health section, we discussed how modern medicines have their benefits with a scientifically proven effectiveness, but these medicines can be associated with side-effects or adverse events.
For that reason, we, like all pharmaceutical organizations, have a pharmacovigilance department that closely monitors and controls the safety of our drugs.
What is pharmacovigilance?
Pharmacovigilance is the science and research relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Pharmacovigilance is needed to protect patients and public health by acting as a function that ensures medicines patients take are safe. It is a continuous process lasting through the whole life cycle of a medicine and is needed to complete the knowledge about a medicine’s effectiveness and risk in the real world.
Pharmacovigilance provides updated information to HCPs and patients to minimize risk and to optimize safe and effective use of medicines.
We are committed to patient safety
The framework of our pharmacovigilance operating governance model consists of transversal and multidisciplinary safety governance teams comprised of empowered, senior decision-making individuals with safety, ethics, legal, scientific, medical, clinical, and regulatory skillsets.
How does pharmacovigilance work?
Pharmacovigilance works by first, gathering information about side effects of medications. The second stage is to analyze the information gathered from patients, healthcare providers, medical literature, and research data.
Finally, pharmacovigilance implements the knowledge gathered about a particular drug’s side effects into the clinical setting so healthcare providers can inform their patients about the drug’s safety profile.
How is Sanofi’s pharmacovigilance model different?
Sanofi’s pharmacovigilance incorporates a patient-centric model. Our structured benefit-risk approach helps us to perform quick and efficient analysis of safety profiles. This enables us to have a very rapid process from signal detection to the patient’s leaflet.
In addition, the team leverages cutting edge technology that has artificial intelligence and machine learning applications for adverse event identification. Of course, at Sanofi, pharmacovigilance is integrated in all corporate policies.
How can I contribute to Sanofi’s pharmacovigilance efforts?
Pharmacovigilance is a well-oiled global machine of thousands of experts working for patient safety. Information is gathered from millions of patients and HCPs. Your voice and your experience about any possible adverse reaction is critical for us to know.
You can contribute to the safety of your medicine by reporting any adverse reactions to your physician or to Sanofi directly.