Tomomi Otani
Drug Safety Specialist @Spm -Safety Projects & More Gmbh
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WORK HISTORY
Drug Safety Specialist @Spm -Safety Projects & More Gmbh
Leading international PV teams and managing global safety activities- Processing AEs/ICSRs (Phases I–IV) and ensuring timely SUSAR reporting- Supporting DSURs and managing audits, inspections- Conducting literature reviews and contributing to safety documentation- Handling database reconciliation, PV compliance monitoring, and partner coordination etc.
EDUCATION
Institute of Science Tokyo (Science Tokyo)
Master of Science - MS
Tokyo Medical and Dental University
Master of Science (M.Sc.), Medical Biology
SKILLS
ABOUT TOMOMI OTANI
The German and Japanese versions are provided below:With over 10 years of experience across Japan and Europe, my background integrates deep expertise in Pharmacovigilance and clinical development with strong leadership in multicultural environments. Key strengths include driving complex international projects, building global PV systems, and aligning diverse stakeholders toward shared goals. Serving as a bridge between Japan and Europe, I contribute to efficient, high-quality drug development and foster productive international collaboration.Mit über 10 Jahren Erfahrung in Japan und Europa vereine ich umfassende Expertise in Arzneimittelsicherheit (Pharmakovigilanz) und klinischer Entwicklung mit ausgeprägter Führungskompetenz in multikulturellen Teams. Zu meinen Stärken zählen die erfolgreiche Steuerung komplexer internationaler Projekte, der Aufbau globaler PV-Strukturen und die effektive Vernetzung vielfältiger Stakeholder. Als Brücke zwischen Japan und Europa trage ich zu einer effizienten, qualitativ hochwertigen Arzneimittelentwicklung und einer nachhaltigen internationalen Zusammenarbeit bei.PV10 I–IV EMA/MHRA/FDA/PMDA/TGA PV
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