A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. The European Medicines Agency, together with the regulatory authorities in the Member States and Marketing Authorization Holders are responsible for detecting and managing safety signals.
Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. The EudraVigilance database is also an important source of information on suspected adverse reactions and signals.
The evaluation of safety signals is part of routine pharmacovigilance and is essential to greater patient safety and improved public health through better detection, assessment, understanding and prevention of adverse reactions. Through our experienced and highly qualified staff, we at PharmaCons can offer advice and collaborate with you to make sure your Safety Signals Management activities are comprehensive and your actions always timely, accurate and compliant.
- Support for managing and tracking signals
- Timely analysis of all potentially and relevant data
- Assessment of detected signals
- Review and evaluate the scientific literature and provide a comprehensive and rigorous overview
- Validation, prioritization and confirmation processes for signals
- Recommendations for next actions in accordance with EU requirements and best practice guidelines
- Ongoing surveillance and active monitoring for drug portfolio