Consultant for the Development and Maintenance of Pharmacovigilance (PV) Quality Management System (QMS) (m/f)

REFERENZNUMMER:

365019/1

IHRE AUFGABEN:

-Implement and administer pharmacovigilance quality management systems to ensure best practice and continuous improvement of the global patient safety
-Developing PV intelligence and gap analysis process
-Support the QMS Manager in ensuring that detailed systems and procedures are in place in accordance with company group guidelines, policies and procedures and relevant guidelines
-Review and update of PV SOPs and templates
-Maintain key performance indicators for all relevant internal and external departments/organizations as required by the business.
-Ensuring oversight of the status of PV metrics by an up-to date dashboard
-Supporting PV Strategy Office team with regard to training needs
-Creating agendas, management invitations, collation of slides and generation and distribution of meeting minutes
-Active participation in audits/inspections

IHRE QUALIFIKATIONEN:

-Profound experience in pharmacovigilance
-Management of trainings
-Good PV knowledge (post-marketing)
-Good pharmacovigilance (PV) quality systems, legislation knowledge
-English (business fluent)
-German (beneficial)
-Organizational, prioritization skills

WEITERE QUALIFIKATIONEN:

Drug safety manager