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.

Job Summary

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/Affiliates, as applicable.

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.

Job Description

Responsibilities

Quality and Compliance:

• 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.
• 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.
• 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.
• 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.
• Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
• Collaborates with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings. 

Responsibilities Continued

Training Program:

• 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 as applicable. Collaborates with relevant functions and management for new staff on-boarding 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, 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. 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/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:

• Procedural Document Program: Takes a lead role in the development and enhancement 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. Drives the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.). Coordinates training curriculum for each function within CSPV and ensures the appropriate documentation is contained within the training profile.
• Procedural Document Development and Delivery: Takes a lead role in the 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. Supports process redesign initiatives by updating relevant documentation for changes to processes.
• 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

Education Qualifications

• Bachelor's Degree, preferably in healthcare or life sciences, required
• Master's Degree, PharmD, RN preferred

Experience Qualifications

• 4+ years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required.
• 7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred
• 4+ 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 
  
  

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.

Salary Range:

USD$124,960.00 - USD$187,440.00