Outsourcing of individual pharmacovigilance tasks
The area of drug safety covers a broad spectrum of tasks. We would be happy to take over the timely processing of all the work that arises in this area as well as the long-term management of various projects for you.
- Periodic Safety Update Reports (PSURs/PBRERs) / Addendum to Clinical Overview (ACO)
- Risk Management Plans (RMPs)
- Signal Management
- Safety Data Exchange Agreements (SDEAs)
- Literature searches international / local
- Evaluation of adverse event reports
- Provision of local contact facilities for adverse reaction reports (e-mail / hotline)
- Editing of safety-relevant sections in technical information and directions for use
- Answering medical-scientific questions
- Preparation of pharmaceutical-medical statements and expert opinions (Clinical Expert Statement)
- Medical-scientific presentations and materials
Establishment and optimisation of pharmacovigilance systems
Quality management is becoming increasingly important within pharmacovigilance and has long been the central topic of inspections. To ensure that you are well positioned in this area, we offer, among other things, the preparation of the following documents and support for the following topics:
- Preparation and review of the Pharmacovigilance System Master File (PSMF)
- Analysis and optimisation of the existing pharmacovigilance system
- Preparation and follow-up of inspections and audits
- Conducts of audits
- Preparation of Standard Operating Procedures (SOPs)
Implementation of pharmacovigilance processes - Training of staff
- Assumption of activities as QPPV and qualified person for pharmacovigilance
- Consulting on EudraVigilance
- Consulting on data protection
In addition to our central themes in drug safety, we offer a range of other services in the field of medical writing. If you have any further requirements, please do not hesitate to contact us!