Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
This position supports the head of CSPV Quality, Compliance & Training in the establishment, implementation and oversight of the CSPV Quality, Compliance and Training function. This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions. This role is the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality Assurance and License Partners. This position is responsible for facilitating audit and inspection-related activities within CSPV and supports the development of inspection readiness initiatives. This position is responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements. With support from the head PV Quality, Compliance & Training, this position will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met. This position is responsible for the design and development of a procedural document management program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable This position liaises with CSPV management and cross-functional teams as necessary throughout the corporation to drive a culture of regulatory compliance and ensure effective and efficient management of CSPV activities.
- Quality and Compliance:
o Manages activities related to quality and compliance including but not limited to 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.
o Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
o Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
o 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; assigning roles and responsibilities for each audit/inspection.
o Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
o Collaborates with members of inspection team and other colleagues including Head of Quality Assurance to ensure optimum responses to audit/inspection findings.
- Training Program Management:
o Training Program: Takes a lead role in the design and development of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training at DSI.
o Training Plan and Delivery: Takes a lead role in the design and development of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff as needed. Oversees the quality and consistency of training conducted within CSPV. Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training at DSI. Resolves and responds to training issues and questions.
o Training Records and Maintenance: Works with Quality and Compliance to identify training compliance, and coordinates escalation of non-compliance. Works with DSI's LMS Administrator to generate/access necessary training reports and to ensure proper training documentation. Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements as necessary. Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments). Ensures training processes and relevant materials are up-to-date. May participate in creation, review, and revisions to controlled documents and procedures.
- Procedural Document Management:
o Procedural Document Program: Takes a lead role in the design and development of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable. Program will give the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.). Coordinates with the CSPV Training Manager, the correct profiles for each function within CSPV and ensures the appropriate documentation is contained within the training profile.
o Procedural Document Development and Delivery: Takes a lead role in the design and development of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates). Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents. Strives to ensure the process is optimized for efficiency and clarity. Ensures associate understanding of the process documented and resolves and responds to documentation issues and questions. Supports process redesign initiatives by updating relevant documentation for changes to processes.
o Procedural Document Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents. Responsible for inspection readiness activities related to documentation. Supports all internal and external partner audits for documentation requirements.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree preferably in healthcare or life sciences required
- Master's Degree preferred
- PharmD preferred
- RN preferred
- 4 or More Years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment preferred or
- 7 or More Years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred
- 4 or More Years of direct experience in Pharmacovigilance Compliance, global setting preferred
- Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines preferred
N/A N/A% of Time
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.