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Pharmacovigilance

The EU pharmacovigilance legislation from July 2012 has implications for you as  Marketing Authorisation Holder. At LINK Medical, you will find all the expertise you need. Our specialized consultants can guide you through the process and implement the Good Vigilance Practice for medicinal products for human use as well as the guidelines for medicinal products for veterinary use and medical devices.

All our services can be delivered from either our office or from your own premises.

  • Electronic reporting (EudraVigilance,EudraVigilance Veterinary)
  • Registration of product information in the eXtended EudraVigilance Medicinal Product Dictionary
  • Literature searches - local and worldwide
  • Medical coding (MedDRA, VedDRA)
  • Medical evaluation
  • Pharmacovigilance System Master File
  • Risk Management Plan
  • Standard Operating Procedures
  • Signal detection and evaluation
  • Device vigilance
  • Training

Let our highly experienced and dedicated team deliver an individual solution that suits
your pharmacovigilance system.

Related links:



Download our Pharmacovigilance flyer 
Updated

Related contacts:

brit
Brit Moe
Safety Group Lead
Norway
Tel:+47 92 83 86 19
brit@linkmedical.no

Ewa Lyzell
Safety Group Lead
Sweden
Phone: +46 (0)730 32 93 53
marianne@linkmedical.se

 

7119 Anne K
Anne Krammer
Director Regulatory & Safety 
Denmark
Tel: + 47 61 67 32 15
annek@linkmedical.dk
6491smallweb
Uwe Anzenberger
General Manager
Germany
Tel +49 (0)30 2129 5348
Cell phone +49 (0)170 549 8940
uwe.anzenberger@link
medical.de