Manager PV Operations ICSR Standards (m/f/d) - #2747808

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.
  
  

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.