Pharmacovigilance

As a pharmaceutical company, the drug safety is of high importance for us. Our experienced pharmacovigilance team supports you reliably and efficiently with the corresponding tasks. We monitor the safety of drugs in our responsibility by collecting and evaluating all drug risks.

Role and Responsibility:

Establishhment and maintanance of the pharmacovigilance system:

  • Pharmacovigilance System Master File (PSMF): MFL 9128

Supervision and maintenance of the pharmacovigilance system by our qualified employees:

  • EU-QPPV and deputy QPPV
  • Graduated Plan Officer (§ 63a AMG)
  • 24-hours reachability for Regulatory Authorities

Commitment:

  • Our PV team is ready to meet your challenge
  • Reliable and target-oriented partnership
  • Preparation and maintenance of pharmacovigilance documentation for approval by Regulatory Authorities

Compliance:

  • We work in compliance with EU-GVP and national pharmacovigilance legislation

Your Contact

Larissa Gutenmacher-Ruf

Larissa Gutenmacher-Ruf

Pharmacist
Director Pharmacovigilance/EU-QPPV

Midas Pharma GmbH
Rheinstr. 63
55218 Ingelheim
Germany

Share this page