Pharmacovigilance

Pharmacovigilance is all about the quest to have safe and efficient products on the market. By collecting and carefully monitoring all side effects, properly reporting the data to the health authorities and being prepared to act – always with the patient’s safety in focus – the vision of safe and efficient products can be met.

We can manage your products safety data in Sofus PV database, make your MedDRA-coding and report your cases to Eudravigilance.

This is how Sofus help can help your company fulfil the regulatory requirements:

• Contract staffing
• Manage safety data in Sofus PV database.
• Make your MedDRA-coding
• Take your QPPV responsibility
• Handling of your ADRs/AEs
• Report your cases to Eudravigilance
• Be your medical back up
• Write your DDPS and SOPs
• Perform literature searches
• Educate your personnel

To view the complete brochure, please click here.