PHARMACOVIGILANCE

Our pharmacovigilance specialists have extensive experience in this field. We are able to offer you the following:

Services
Comments

Establishing of pharmacovigilance system:

  • The system will be established exclusively for your situation.
  • We have an experienced Qualified Person for Pharmacovigilance (QPPV).
  • We have access to EudraVigilance database (processing of ICSRs, submission of product information).
  • Literature screening.
  • Staff training.
  • Preparation of local standard operating procedures.
  • Communication with competent authorities.
  • Support during audits.

 

 

 

 

Applies to:

LATVIA, LITHUANIA, ESTONIA

Acting as Local Safety Contacts. This includes:

  • Preparation of local Standard Operation Procedures (SOPs);
  • Local database for safety information;
  • Signal detection;
  • Local literature screening;
  • Trainings;
  • Submission of relevant documentation (reports, PSURs, etc.);
  • Communication with competent authorities;
  • Support with the case on the national level (follow-up, translation, local database, etc.);
  • Other related tasks.

 

 

 

 

 

Applies to:

LATVIA, LITHUANIA, ESTONIA

 

Trainings

  • We are ready to train you and your staff, which is an easy way to be in line with legislation and to keep you up to date.

 

These can be in-house trainings or distance learning.

There are a lot of pharmacovigilance activities, and we are ready to offer you all that is needed in your situation. We are able to customize these services for you, so please feel free to contact us for further information: phvig@snovigroup.com