regulatory environment 5. Provide advice and act as project liaison · Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior
Management and employees · Be accountable for quality-related input in decision making processes with relevance for GxP compliance · Act as quality liaison for assigned projects … in Pharmacovigilance auditing (Qualification as an auditor preferred) · Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality
Management for Pharmacovigilance or Clinical Development or Computer System Validation · Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of … Pharmacovigilance, Clinical Development, Medical Device, IMP
management, Regulatory Affairs and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and CAPA
management · Understanding of
change management processes · Well versed with MS Office (advance
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