The National Responsible Person for Pharmacovigilance is responsible for ensuring that pharmacovigilance activities required for Belgium and Luxembourg are undertaken in line with the pharmacovigilance requirements of the company and applicable legislation. The responsibility applies for all Marketing Authorisations held in the country for the MAHs and where the MAH has pharmacovigilance agreements with third party MAHs. Local activities include the implementation of global and European procedures and the creation of local procedures, PV training for all local staff, compliance monitoring, reconciliation, and archiving of local pharmacovigilance and regulatory documentation. The role will also require do perform RA tasks and any other tasks assigned by the head of Pharmaceutical Affairs.
Reporting line to: Head of Pharmaceutical Affairs Belgium/Lux
KNOWLEDGE AND EXPERIENCE