Pharmacovigilance quality system 

 

• Planning, ensuring, controlling and improving quality management of Pharmacovigilance System.

• Organization and carrying out of internal audit (self-inspection) of Applicant’s Pharmacovigilance System.

• Constant compliance monitoring of Pharmacovigilance System with requirements of current legislation.

• Initial and periodic training of company’s staff on monitoring the safety and efficacy of medicinal products in accordance with regulatory requirements.