Pharmacovigilance Services
Pharegistrum supports companies with pharmacovigilance activities and the organisation of system documentation. Services include the person responsible for pharmacovigilance, literature searches and preparation of safety reports.
Organising the pharmacovigilance system
Support is defined according to the company’s activities and needs, and may cover system implementation and the preparation of associated procedures.
- Qualified person responsible for pharmacovigilance (QPPV).
- Preparation of the pharmacovigilance system master file (PSMF).
- Preparation of standard operating procedures (SOPs).
- Support with risk management systems and Good Pharmacovigilance Practices (GVP).
Literature searches and safety follow-up
- Literature searches and preparation of search reports.
- Preparation of periodic safety update reports (PSURs).
- Adverse reaction reporting and follow-up.
These activities complement the organisation of the system and are included according to the agreed scope of each project.
Cosmetovigilance and medical device vigilance
In addition to pharmacovigilance, Pharegistrum offers cosmetovigilance and medical device vigilance services. Activities are defined according to the product category and the client’s needs.
Tell us about your requirements
Describe the products involved, the system currently in place and the activities for which you need support. This information enables us to prepare a service proposal adapted to your company.
