1. Adverse event monitoring and reporting:
Pharmacovigilance departments collect, assess, and document adverse events (aes) associated with the company’s products.
They establish systems and processes for the timely and accurate reporting of aes from healthcare professionals, patients, and other sources.
The department evaluates the reported aes to determine their severity, causality, and potential impact on patient safety.
Adverse event data collected by pharmacovigilance contribute to safety signal detection, risk assessment, and regulatory reporting.
2. Safety signal detection and evaluation:
Pharmacovigilance professionals monitor and analyze safety data to detect potential safety signals, which are potential new risks or changes in the known safety profile of A product.
They assess the significance and clinical relevance of safety signals through rigorous analysis of the available data.
The department collaborates with regulatory authorities, scientific experts, and other stakeholders to evaluate and validate safety signals.
3. Risk assessment and benefit-risk evaluation:
Pharmacovigilance plays A critical role in assessing the benefit-risk balance of pharmaceutical products.
They contribute to the ongoing evaluation of the safety and efficacy of products through comprehensive risk assessments.
The department provides recommendations to the company and regulatory agencies regarding risk management strategies, including updates to product labeling, risk minimization measures, and post-marketing studies.
4. Regulatory compliance:
Pharmacovigilance ensures compliance with local and international regulations and guidelines related to the safety monitoring and reporting of pharmaceutical products.
The department stays updated with regulatory requirements and ensures timely submission of safety reports and other regulatory obligations.
5. Pharmacovigilance operations and systems:
Pharmacovigilance professionals establish and maintain robust systems and processes for efficient data collection, management, and analysis.
They implement pharmacovigilance databases and tools to facilitate the reporting, tracking, and evaluation of safety data.
The department ensures that standard operating procedures (sops) are in place for pharmacovigilance activities and that staff members are properly trained.