Manager, PV Quality Management

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.

This position supports the head of CSPV Quality, Compliance & Training in the establishment, implementation, and oversight of the CSPV Quality, Compliance and Training function. The role is responsible for managing activities related to quality and compliance including monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions. It serves as the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities and PV audits conducted by DS Quality Assurance and License Partners/Affiliates.

The position facilitates audit and inspection‑related activities within CSPV, supports the development of inspection readiness initiatives, and identifies training needs for CSPV staff. It develops and oversees training programs and procedural document management to ensure regulatory compliance.

• Manage activities related to quality and compliance, including monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
• Drive and manage an effective corrective action and preventive actions (CAPA) process, including tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
• Lead audit/inspection readiness activities, including conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
• Support conduct of inspections and audits and closely collaborate with Global GCP/PV‑QA audit department in preparation of internal audits and regulatory inspections, including preparation, review and provision of relevant documents and assigning roles and responsibilities for each audit/inspection.
• Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
• Collaborate with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings.

• Takes a lead role in the development and enhancement of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions. Collaborates with relevant functions and management for new staff onboarding and general safety reporting training.
• Training Plan and Delivery:
  Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff. Oversees the quality and consistency of training conducted within CSPV. Resolves and responds to training issues and questions.
• Training Records and Maintenance:
  Monitors training compliance and coordinates escalation of non‑compliance. Works with LMS Administrator to generate and access necessary training reports and ensures proper training documentation.
• Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements. Supports the annual roll‑out of the Adverse Event Reporting Policy Training assigned to all company staff globally, managing project implementation, content updates, evaluation of training adequacy, and distribution of training.
• Ensures…