Self-Service Business Intelligence solution to pharmacovigilance signal management

The main goal of this thesis is to analyse signal management processes within pharmaceutical industry companies and then to propose a Self-Service Business Intelligence solution which could be used to streamline the processes. Theoretical part of the thesis introduces the science of pharmacovigilance focusing on signal management processes and outlines the EU regulatory framework and legal requirements. Practical part then contains the analysis of the processes and guidelines. Based on the results of this analysis, proposes an SSBI solution. The main contribution of this thesis is development of an integrated and centralised tool for standardized tracking of information regarding adverse events caused by a medicine throughout their lifecycle. This tool with various dashboards enables the management to monitor compliance metrics, facilitate resource management and provide a visual overview for the companies as well as for the clients. Implementation of this solution could lead to improvement of decision-making skills of its stakeholders, leading to a consistent process void of scattering to protect patients and public health.