QPPV

Catafago

Ensures that the marketing authorization holder (MAH) complies with pharmacovigilance regulations and guidelines.

Establish and maintain a pharmacovigilance system that collects, evaluates, and reports adverse events and safety data. This includes maintaining a Pharmacovigilance System Master File (PSMF), which provides an overview of the pharmacovigilance system.

Develop and implement pharmacovigilance training for all relevant personnel within the organization.

Conducts ongoing risk assessments to identify potential safety concerns and takes appropriate measures to mitigate risks. Review and update the Risk Management Plans, focusing on marketing authorization commitments and risk minimization measures.

Monitor and review safety signals, including any open signals that require further investigation.

Responsible for the timely submission of periodic safety update reports (PSURs) and other required safety reports to regulatory authorities.

Oversee the exchange of safety data through Safety Data Exchange Agreements (SDEAs) with partners and stakeholders.

Interacts with key stakeholders and contacts, such as healthcare professionals, patients, regulatory bodies, and vendors/partners.

Regularly review and monitor local literature for potential safety signals, new adverse events, or emerging safety concerns related to our products.