Leutershausen, Baden-Württemberg, Germany
Experienced and highly motivated professional with about 20 years of experience in Pharmacovigilance (PV), including ICSR management, data enty into safety database, coding and narrative writing, as well as reconciliation. Expertise in safety regulatory intelligence, ensuring regulatory compliance, attending internal and external audits and managing CAPAs. In addition, being involved in signal detection and safety evaluation activities, as well as PSUR generation. Process owner being responsible for developing, updating and maintaining SOPs and Work Instructions. Identifying and implementing process improvements and other ways to improve efficiencies on a regional or global level. Monitoring of projects to assure company profitability and associated project goals and objectives are being met. Business system owner for safety case tracking system, and SME for several other safety systems. Forward-thinking leader with comprehensive experience in leading business development, and managing operations while delivering exceptional safety services. Successfully leading and developing high-performing safety experts in Germany and UK.