Pharmacovigilance

Medfiles pharmacovigilance services for human/veterinary medicinal products and medical devices.

Handling of adverse events 

• Evaluation and reporting of spontaneous and literature reports and adverse events in clinical trials
• CIOMS reports and translations (several European languages)
• Electronic transmission of expedited safety reports (Eudravigilance)
• Registration of product information in EudraVigilance Medicinal Product Dictionary (EVMPD)
• Acting as the contact person with local authorities
• Local and global literature searching
• Medical coding of adverse effects (MedDRA, VedDRA)

Periodic safety update reports, non-clinical/clinical safety reports

• Writing and submission

Clinical trials

• Handling of adverse events
• Expedited reporting
• Writing and updating of safety sections
• Preparation of safety reports

Pharmacovigilance system and its detailed description

• Set-up, updates, maintenance, consultation

Signal detection in pharmacovigilance

• Long-term follow-up and detection of drug safety information

Risk management

• Operative risk management tasks
• Updates to risk management plans
• Risk-benefit assessments

Acting as Qualified Person for Pharmacovigilance (QPPV)

• 24/7 service readiness
• Set-up and maintenance of pharmacovigilance systems

Quality assurance

• Standard operating procedures (SOPs): writing and consultation
• Audits of pharmacovigilance systems

Product defects, medical information services

• Coordination and handling of client/end-user enquiries

Consultation and training on pharmacovigilance