Pharmacovigilance is the science of monitoring, evaluating, and preventing adverse drug reactions and other drug-related problems. It is a critical component of drug development and patient safety. The pharmaceutical industry is highly regulated, and regulatory authorities require pharmaceutical companies to adhere to strict pharmacovigilance standards to ensure patient safety.
Pharmacovigilance is essential for detecting and assessing the risks associated with drugs, which can arise from various sources such as clinical trials, post-marketing surveillance, and other sources of data. The regulatory authorities such as the FDA, EMA, and other regulatory bodies require pharmaceutical companies to report all suspected adverse reactions to marketed drugs.
The pharmaceutical industry faces various challenges in pharmacovigilance, including inadequate resources, shortage of skilled personnel, and the increasing volume of adverse events reporting. Pharmaceutical companies need to be proactive in addressing these challenges to ensure compliance with regulatory requirements and maintain public trust.
Vigilare Biopharma offers a range of pharmacovigilance services to meet the needs of the pharmaceutical industry. Our pharmacovigilance experts have extensive experience in managing pharmacovigilance operations for global pharmaceutical companies.
Medical Information call-center
Case processing
Medical literature monitoring
Surveillance and signal management
Aggregate report preparation
Safety database management
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Pharmacovigilance
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