Pharmacovigilance

We offer professional services for pharmacovigilance outsourcing to subjects of circulation of medicinal products:

 

Generation of Pharmacovigilance System:

• Development of Pharmacovigilance System Master-file (PSMF) including based on the appropriate detailed description of Pharmacovigilance System (DDPS).
• Development of SOPS in accordance with the requirements of contracting parties or Regulatory Authorities (collection and processing of spontaneous reports, reporting to Regiulatory Authorities, PSUR, risk management plan…).
• Development, creation and validation of pharmacovigilance database (in case a company lacks it).
• Development of Safety Data Exchange Agreements (SDEAs) with contracting parties.
• Development of audit plan and pharmacovigilance inspection plan for contracting party and your company.
• Development of pharmacovigilance training plan and training multimedia classes.
• Conducting monitoring of web-sources and literature, search for information on drug safety and efficiency.
• Development of Risk Management Plans (RMPs) for Marketing Authorization.
• Development of Periodic Safety Update Reports (PBRERs/PSURs) and ACOs.
• Preparation of Development Safety Update Reports (DSURs).
• Establishment, processing and subsequent signal management.
• Development of Company Core Safety Information (CCSI) for Marketing Authorization.
• Pharmacovigilance System quality management.
• Monitoring of compliance of Pharmacovigilance System with the requirements of current legislation.

 

Postmarketing pharmacovigilance:

• Organization of the process for collecting, processing, coding of spontaneous consumer reports, inclusion of information in the pharmacovigilance database (case processing).
• Organization of the process for urgent AE notification (subject to urgent reporting).
• Literature screening (regular monitoring), preparation of literature reviews of drug safety.
• Preparation of PSURs • Management of drug safety signals.
• Provision of services of the Qualified Person for Pharmacovigilance (QPPV)