Our comprehensive and fully compliant pharmacovigilance system adheres to the highest industry standards, Good Pharmacovigilance Practices (GVP), EU and local regulations. Designed to guarantee patient safety, it incorporates a robust quality management system and supports the expectations and standards of our partners. We keep the pharmacovigilance system audit- and inspection-ready at all times, incorporating the latest requirements for digitalization, data security, and business continuity.
Our pharmacovigilance services include:
- Local Qualified Persons for Pharmacovigilance with 24/7 availability
- Management of safety information reports
- Local literature and regulatory intelligence
- Submissions and communication with local regulatory authorities
- Local adaptation and distribution of risk minimization measures
With our dedicated team of pharmacovigilance specialists, we maintain a robust Medis pharmacovigilance system. It adheres to the highest standards of our partners, as well as EU and local regulations, prioritizing patient safety.Teja PoglajenGlobal Drug Safety Manager, Medis EEA QPPV