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)
