Beschreibung
We are looking for a
Consultant for the development and maintenance of Pharmacovigilance (PV) Quality Management System (QMS) (m/f)
Reference: -en
Start: asap
Duration: 3 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Drug safety manager