• Global Risk Management Plan (RMP) Manager Coordination of activities to support RMP submissions for innovative medicines (e.g. Neuroscience, Oncology)• Workstream Lead – Sandoz Separation Establishment of an independent generic safety organization from feasibility assessment to implementation and transition, incl. external stakeholder management (i.e. QPPV-office, PSMF, QMS, Safety Governance, and Business Continuity… Show more • Global Risk Management Plan (RMP) Manager Coordination of activities to support RMP submissions for innovative medicines (e.g. Neuroscience, Oncology)• Workstream Lead – Sandoz Separation Establishment of an independent generic safety organization from feasibility assessment to implementation and transition, incl. external stakeholder management (i.e. QPPV-office, PSMF, QMS, Safety Governance, and Business Continuity Plan)• Subject matter expert (SME) for contractual agreements (mergers, acquisitions, separations). Certified lecture at the EU2P-programme.• Study Lead for Sub-study 2.5.4 at IHI ConcePTION, a European government and EFPIA-funded consortium [A demonstration project that focusses on the collation and analysis of reported pregnancies].• SME for Pregnancy Prevention Programmes (PPP) and Controlled Distribution Systems (CDS). Speaker at the DIA and FORUM Institut. • Strong partnership with the QPPV-office for scientific publications, pharmacovigilance topics, maternal health and environmental aspects of the EU regulation overhaul. Show less

Implementation of Pregnancy Prevention Program for Lenalidomide and Pomalidomide, Medical Risk Assessments, Signal Detection, RMP

Company Core Data Sheet, Signal Detection

- Medical expert for non-interventional studies (NIS), especially iron chelators- Case processing for all company oncology drugs

- Support of global safety operations unit- Preparation of internal audits and inspections- review of audit reports

• Case processing (non-interventional studies, spontaneous reports) incl. triage, completing the AE form, case transfer in Argus Affiliate• Compliance with national and international legal requirements, guidelines and recommendations as well as pharmacovigilance guidelines• Query management in cooperation with the Drug Safety Department of the customer and study sites• Translation of medical reports / data, review and proof-read of documents (German/English) • Creation of case… Show more • Case processing (non-interventional studies, spontaneous reports) incl. triage, completing the AE form, case transfer in Argus Affiliate• Compliance with national and international legal requirements, guidelines and recommendations as well as pharmacovigilance guidelines• Query management in cooperation with the Drug Safety Department of the customer and study sites• Translation of medical reports / data, review and proof-read of documents (German/English) • Creation of case reports in English, e.g. CIOMS, narrative writing• Screening of clinical data for reportable events and events of special interest• Preparation of required scientific information for experts as well as information for patients• Training of newly hired employees Show less

• Preparation of internal audits and inspections by authorities (Review of audit reports, tracking and monitoring of Corrective Action Plans (CAP); CAP Coaching• Correspondence with national Authorities, especially MHRA (Medicines and Healthcare Products Regulatory Agency, United Kingdom) and BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Germany)• Role of Pharmacovigilance Training Manager for 38 local affiliates: Preparation, review and organization of training of… Show more • Preparation of internal audits and inspections by authorities (Review of audit reports, tracking and monitoring of Corrective Action Plans (CAP); CAP Coaching• Correspondence with national Authorities, especially MHRA (Medicines and Healthcare Products Regulatory Agency, United Kingdom) and BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Germany)• Role of Pharmacovigilance Training Manager for 38 local affiliates: Preparation, review and organization of training of Pharmacovigilance staff via BAH e-Learning tool• SOP timeliness and review• Maintenance of Pharmacovigilance Compliance Agreements with affiliates, service providers and licensing partners• Maintenance of the Pharmacovigilance System Master File (PSMF) Show less

• Support of clinical studies (Therapeutic Drug Monitoring via LC-MS)• Medical information service• Lectures and sessions for medical students • Lecturer and facilitator at the post graduate programme "Pharmakologie und Therapieforschung", a collaboration of the University of Cologne and Bayer AG

• Deputy Local safety Officer DASHB (Germany, Austria, Switzerland, The Netherlands, Belgium, Luxembourg)• Maintenance and development of local Quality System (SOPs, WIs, etc.)• Collection and assessment of adverse events from all sources• Medical and scientific service for the complete J&J portfolio (all OTC medications, medical products and nutritional supplements)• Training of PV-staff and other employees

• Experimental Ph.D. thesis with regulatory background• Presentation of results at national and international congresses

• Blood typing, serologic testing• Production of blood preservations• Organization of emergency and night service