Pharmacovigilance is the activity that pharmaceutical companies are required to carry out to demonstrate the beneficial/risk ratio of their products. It is a complex and multifaceted process, involving the acquisition and management of a lot of information, their processing and drafting of documents to be submitted within a precise timeframe to national and international regulatory authorities.
The Eureka InfoMed team consists of trained and constantly updated professionals who, thanks to their specific experience, guarantee a scrupulous and timely service.
In addition, we are organized to work with the utmost speed, accuracy and flexibility in roles, in order to offer a quality service always attentive to meet our customer’s expectations.
We offer the Pharmacovigilance service in outsourcing; so that we can provide a solution in the following activities:
- Provision of EUQPPV role
- Drug safety officer
- Periodic Safety Update Report (PSUR)
- Risk Management Plan (RMP)
- Pharmacovigilance System and Pharmacovigilance System Master File (PSMF)
- Eudravigilance screening
- Entry of adverse reaction reports into EudraVigilance
- Managing of ICSR and their follow-up
- Regulatory intelligence website screening (AIFA ed EMA)
- Managing of Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
- Monitoring of medical literature local and International
- Running of specific literature search as per pharmacovigilance
- Building up the adapt searches as per pharmacovigilance
- Signal Detection
- Pharmacovigilance in the clinical trials