Signal Management

A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. Safety signals can be detected from various sources, such as spontaneous reports, clinical studies, and scientific literature. The EudraVigilance database (EVDAS) is an important source of information on suspected adverse reactions and signals.

The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. There could be confounding factors, too.

The assessment of safety signals establishes whether or not there is a causal association between the medicine and the reported adverse event.

Evaluating safety signals is part of the routine pharmacovigilance process. It is essential to ensure that regulatory authorities have the most up-to-date information on a medicine’s benefits and risks.

We have a dedicated team of healthcare professionals and physicians who perform complete signal management activities, including signal detection, validation, analysis and prioritization, assessment, and recommendation for action. We offer highly qualified, dynamic, and multilingual technical expertise for global signal management activities. As per EU guidelines, we also have an expert team for signal detection from the EudraVigilance database (EVDAS). Our signal management team ensures that regulatory compliance is met for MAH.