At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Roles and Responsibilities
- Serve as the DSE PV Operations point of contact for CAPA management, coordinating documentation, follow-up, and cross-functional alignment.
- Perform and oversee reason-for-delay analyses for late case submissions, identifying root causes and improvement actions.
- Support the revision and maintenance of PV Operations procedures and documentation to ensure compliant case processing.
- Facilitate PVRI and PVA reviews, including impact assessment and timely PV Operations input.
- Support audit and inspection readiness by maintaining accurate, complete, and inspection-ready documentation and records.
- Identify process deviations, improvement opportunities, and optimization measures to strengthen compliance and consistency.
- Prepare, review, and support implementation of CAPAs.
- Lead or contribute to process improvement initiatives and projects within PV Operations.
- Resolve or escalate case processing and vendor-related issues in a timely manner.
- Collaborate effectively with CSPV, DS affiliates, cross-functional teams, and external partners.
Education & Experience
- Bachelor’s degree or higher in Life Science, Pharmacology, Medicine, or related field.
- Minimum 5 years of PV experience, or 7 years total relevant experience.
- Strong knowledge of European and international PV regulations.
- Experience across multiple PV Operations areas, especially interventional and non-interventional trials.
- Technical experience in electronic data capture and safety reporting preferred.
- Excellent computer skills.
- Excellent English language skills.
Manager PV Operations ICSR Standards (m/f/d) in München Arbeitgeber: Daiichi Sankyo
Daiichi Sankyo bietet Ihnen die Möglichkeit, Teil eines innovativen Unternehmens zu werden, das sich der Verbesserung des Lebens von Patienten weltweit verschrieben hat. Mit einem starken Fokus auf Inklusion und Vielfalt fördern wir eine Kultur des gegenseitigen Respekts und kontinuierlichen Lernens, während wir Ihnen gleichzeitig zahlreiche Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung bieten. Arbeiten Sie in München in einem hybriden Arbeitsumfeld, wo Ihre Ideen geschätzt werden und Sie aktiv zur Gestaltung einer gesünderen Zukunft beitragen können.
