Global Pharmacovigilance Auditor
vor 2 Wochen
Ihr Aufgabengebiet
- Management and execution of several internal PV audits
- Development and implementation of PV audit strategies in collaboration with QPPV and R&D departments
- Ensuring the conduct of GVP audits at external sites and internal departments
- Monitoring processes/systems according to internal and external GVP requirements
- Definition of CAPAs in collaboration with the QPPV office and PV operations teams
- Review and approval of audit responses both internally and externally
- Act as an SME during during global regulatory agency inspections and other IT office audits regarding the GVP-Compliance
Ihr Hintergrund
- Bachelor’s degree in natural sciences or equivalent education
- Several years of experience in the pharmaceutical industry (minimum 5 years)
- Ideally, 5 years of experience in the field of pharmacovigilance/GVP
- Excellent knowledge of global GVP, GCP, and quality risk management regulations and guidelines
- Experience with validation of computer Systems
- Experience writing comprehensive audit reports and documentation for management, as well as other supporting areas
- Excellent English language skills, both oral and written
- Willingness to travel worldwide (approx. 40%) as part of the audits
Ihre Benefits
- A modern workplace
- Exciting opportunities in an evolving and fast growing company
- Challenging and varied projects
- Multicultural and highly professional team
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package
- Diverse corporate benefits
Gender-Hinweis
Aus Gründen der besseren Lesbarkeit
wird auf die gleichzeitige Verwendung
der Sprachformen männlich, weiblich
und divers (m/w/d) verzichtet.
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