Specialist Global PV System - QM

As Specialist Global PV System in the area of quality management (QM) for pharmacovigilance (PV), you will work in a global function, take over the documentation of all compliance processes in the Global PV System of the STADA Group and provide support in PV-related QM processes.

• Documentation of non-compliances with PV processes as laid down in standard operating procedures (SOPs) and PV Agreements with contractual partners
• Follow up of Corrective and Preventive Actions (CAPA)
• Electronic administration of SOPs and SOP trainings in the Quality Management Systems
• Coordination of PV and SOP trainings including documentation and success control
• Back-office support for PV audits and inspections (coordination, preparation and follow-up)
• Administrative audit activities including preparation of the audit agenda, plan and report, as well as correspondence with auditees
• Updating of the Pharmacovigilance System Master File (PSMF) including quality checks and final compilation
• Support of Local Pharmacovigilance Units in terms of PV Quality
• Reference: CpiJROwscQaxWqna_fZTCwbXG9b9sWVnd84GDsqtXVzK9YXyd4fKpbzjFIIwd7lz

• University degree with preferably professional experience in the pharmaceutical industry in the area of pharmacovigilance and quality management
• Good communication skills
• Fluent in English (orally and in writing)
• Responsible, careful and independent work
• Structured, result-oriented work style
• Very good software skills (MS-Office)

• Private healthcare insurance (with the option of privileged use for family members)
• Ongoing professional development through specialized education and training
• A platform for learning 14 foreign languages, using various learning styles, including conversation courses
• Personalized mental health and wellbeing support for employees and their families through the Kyan Health app