With our dedicated team of pharmacovigilance specialists, we maintain a robust 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, EEA QPPV

Pharmacovigilance

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
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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