Pharmacovigilance/Clinical Safety - read more

The AMS  Clinical Safety team provides you with the full safety service range or custom-made single service packages according to your needs:

  • Implementation of the EU Pharmaceutical Package (PV-System Audits, data entry of adverse reactions, etc.)
  • Preparation of the Pharmacovigilance System Master File (PSMF)
  • Preparation of Risk Management Plans (RMP)

In case of a temporary or permanent capacity bottleneck of sufficiently experienced staff:

  • Outsourcing of either the entire pharmacovigilance skillset or any single task like:
    • Graduated Plan Officer (Stufenplanbeauftragter, Germany)
    • Qualified Person Responsible for Pharmacovigilance (EU QPPV)
  • Preparation of Periodic Benefit Risk Evaluation Reports (PBRER, formerly PSUR), etc.
  • Implementation and/or execution of clinical safety services for Non-interventional Studies (NIS) and/or Clinical Trials (CT)
  • Support of an investigator regarding an Investigator Initiated Trial (IIT) 

Take advantage of AMS  competency and reliability!

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• 2021 – New Literature Search tool launched • 2021 – DIGA dossier submission pioneer • 2021 – NIS-eTMF launched • 2021 – MDR readiness, AMS prepared for Medical Device Trials under new regulation • 2021 – VO (EU) 536/2014, AMS among the first 100 participants in the EMA CTIS Trainer Programme • 2021 – eSignature, AMS introduced DocuSign® • 2017 – Globally unique AMS-ePRO® features • 2016 – CRO of the year award •

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