Career - Offer

Senior Specialist/Manager Pharmacovigilance

Type of job: full-time

Scope of work:

The PV Specialist is responsible for maintaining the pharmacovigilance system to ensure that information regarding all suspected adverse reactions which are reported to the personnel of the registration holder, is collected and collated in order to be accessible in at least one point within the community.

The PV Specialist is responsible for having an overview of the safety profiles and any emerging safety concerns in relation to medical products for which the company carries out pharmacovigilance activities.

The PV Specialist acts as a single contact point for competent authorities on a 24 hour basis. The PV Specialist may delegate specific tasks, under supervision, to appropriately qualified and trained individuals in a documented fashion. The oversight of any delegated duties remains with the PV Specialist at all times. The PV Specialist must have oversight of the Marketing Authorisation Holder´s pharmacovigilance system in all relevant aspects, including quality control and assurance procedures and compliance reports. The PV Specialist is responsible for ensuring that a system is set up for regular audits. The PV Specialist will attend Inspections and audits from company's clients and Healthcare authorities. In case of absence of the PV Specialist, the responsibilities of the PV Specialist will pass to the Deputy PV Specialist. It is the responsibility of the PV Specialist to ensure that the Deputy is kept up to date on all pharmacovigilance activities relating to the company to enable the Deputy to stand in at any given time.

Requirements: