PHARMACOVIGILANCE.

Pharmacovigilance is a demanding area with complex legal requirements. We help you to fulfill all requirements.
Our team of trained experts develops with you your tailor-made PV system. Our services include:

• Tailor-made solutions for your pharmacovigilance responsibility
  
• Providing a temporary staff member for your pharmacovigilance department (e.g. holiday replacement)
  
• EU-QPPV/deputy function
  
• Country specific responsible person for pharmacovigilance – Local Safety Officer (LSO)
  
• Pharmacovigilance quality system set-up and management
  
• PSMF authoring and maintenance
• Case Processing / Eudravigilance reporting
• MedDRA coding
  
• PSUR / PBRER authoring and submission
• Case Processing / Adverse Event notifications to authorities via EVWeb
  
• Eudravigilance (company registration, data entry)
  We take over all activities to register your company in the Eudravigilance Database starting from SPOR via EMA Account Management to Eudravigilance
  
• XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) – data entry and maintenance
• Signal detection
  
• Local and global literature review
  
• Eudravigilance ICSR and MLM download
• Regulatory Intelligence Screening
• Risk Management Plans (RMPs)
  
• Dear Doctor Letters (DHCPC)
  
• Quality Complaints / Recalls
  Reporting of quality complaints and agency contact, recall support and agency communication
• Safety Data Exchange Agreements authoring and review
• Pharmacovigilance Audits and vendor qualification
  
• Preparation for and support during pharmacovigilance inspections

Clinical Trial Safety

• Clinical trial safety officer
  
• EudraVigilance responsible person for non-EU sponsors
  
• SAE/SUSAR processing, reporting, submission
• DSURs