Ensuring Pharmacovigilance Requirements
Establishing a robust pharmacovigilance system, drafting the required risk management plans and SOPs can tie up significant internal resources. Describing these safety measures — in what’s known as the Pharmacovigilance System Master File (PSMF) under Directive 2010/84/EU — is mandatory for marketing authorization.
Diapharm offers practical solutions to make pharmacovigilance (PV) more efficient while maintaining the highest level of safety. This includes reviewing internal safety processes, developing SOPs, and providing appropriate risk management plans and PV systems.
For the PV departments of many companies, Diapharm monitors the safety of approved medicinal products. Depending on client needs, Diapharm can handle individual tasks — such as assessing adverse events (ADRs and SAEs) and ensuring timely reporting — or take on full responsibility for all pharmacovigilance obligations.
EudraVigilance: Reporting and Signal Management
Electronic reporting of suspected adverse drug reactions (ADRs) is carried out via the EudraVigilance database. Such cases must be reported to the EMA-operated database within specified timeframes: 15 days for serious ADRs and 90 days for non-serious ADRs.
The EudraVigilance database must also be monitored for ADR reports from the market — that is, cases reported by patients and healthcare professionals to national authorities (e.g., BfArM).
Diapharm handles signal management and continuous benefit-risk assessments on behalf of pharmaceutical companies, ensuring that drug safety is monitored continuously, reliably, and efficiently.
Responsibility as Local / EU Qualified Person for Pharmacovigilance
Local QPPVs under §63a AMG are responsible for establishing and maintaining a pharmacovigilance system within the company, collecting and evaluating risk reports, and coordinating necessary safety measures. This role requires extensive expertise and 24/7 availability.
Diapharm provides experienced pharmacovigilance officers — such as Qualified Persons for Pharmacovigilance (QPPVs) and Local QPPVs — for pharmaceutical companies across the DACH and Benelux regions and assumes full responsibility for all pharmacovigilance obligations.
