Archemin

Advice & reporting for the chemical and pharmaceutical industries

Local Pharmacovigilance Contact Person

Thu, 12/05/2016 - 3:41pm -- Ludwig Everaert

Archemin has become a main pharmacovigilance service provider for the BeNeLux countries (Belgium, the Netherlands and Luxembourg).

Archemin’s Local Pharmacovigliance Contact Persons have the appropriate qualifications and resources to perform local pharmacovigilance tasks and to report to the European Qualified Person for PharmacoVigilance (24h/24h availability, access to medically qualified persons, linguistic qualifications to address their interlocutors in the national language of their choice and to be able to communicate with the QPPV).

The Archemin team will not be involved in marketing of medicinal products.

Tasks and obligations for the local Pharmacovigilance Contact Person include:

  • conduct all pharmacovigilance activities in accordance with EU and national legislation.
  • inform marketing authorisation holders about national legislation that differs from EU-guidelines.
  • promptly report to the marketing authorisation holder details of any adverse event data, medical enquiries or product complaints.
  • function as the primary point of contact for any safety-related request from local competent authorities
  • collect data on adverse events/adverse drug reactions/special situation reports and gathers missing information from various sources including healthcare professionals, consumers, local competent authorities, medical and/or pharmaceutical representatives…
  • conduct the weekly literature monitoring of world wide and local publications. reconcile safety information on a monthly basis.
  • ensure 24h/24h, 7d/7d availability.
  • provide pharmacovigilance training to the client personnel
datum: 
Thursday, 12 May, 2016