Pharmacovigilance (drug saftey)

Our drug service in the area of pharmacovigilance

Pharma Expertise Consulting supports you from Periodic Safety Update Report (PSUR) preparation to the establishment of complete pharmacovigilance systems. Drug approvals require companies to have a pharmacovigilance system in place (Summary Pharmacovigilance System Master File according to Directive 2010/84/EU). For this purpose, risk management plans and associated Standard Operating Procedures (SOPs) must be established.

We confirm the safety of approved medicinal products. Depending on your needs, we can take on individual tasks such as the assessment of adverse drug reactions (ADRs) / serious adverse events (SAEs) and/or compliance with reporting obligations–or we can create your entire pharmacovigilance system from scratch.

On behalf of your company, we manage the electronic reporting of suspected cases to EudraVigilance as well as the monitoring of the database (signal management) of adverse drug reactions (ADRs). Serious suspected cases must be reported to the database operated by the European Medicines Agency (EMA)  within 15 days (non-serious within 90 days).

As a pharmaceutical manufacturer, you need a step-by-step plan officer (Section 63a of the German Medicines Act) or a Qualified Person for Pharmacovigilance (QPPV) to set up and manage the pharmacovigilance system. This pharmacovigilance officer must be available around the clock, including binding deputy arrangements in case of vacation, illness, etc.

We support you in establishing the pharmacovigilance system as well as in filling the position of the step-by-step plan officer including deputy regulations.

We are happy to support you. Just contact us!