Associate Director, Pharmacovigilance Quality, Compliance & Training (focus on Training Program Management)
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.
Summary - This role has heavier focus on Training Program Management.
This position works under the direction of the Head of CSPV Quality, Compliance, & Training (QCT). This position is responsible for the management, strategic planning, and organization of QCT-related activities in the areas of quality and compliance, audit/inspection readiness, procedural document management, and training program management.
This position is responsible for managing the day-to-day operational activities and making strategic decisions when applicable. This position actively contributes to the strategic direction for process enhancement and redesign and drives achievement of company and departmental goals and objectives. This position contributes to the structuring of business critical workstreams to support the allocation of resources in QCT to meet workload and project resource demands.
This position supports in developing oversight and action plans for to ensure QCT deliverables are met.
This role leads optimization initiatives to ensure maximum efficiency, adherence to timelines, and superior levels of quality and compliance in CSPV deliverables. This role provides leadership and serves as QCT subject matter expert and back-up of Head of CSPV QCT. This role communicates effectively within the CSPV and cross-functionally regionally and globally.
Training Program Management
- Training Program: Lead role in the design, development, and strategic planning of CSPV training programs based on corporate, organizational and individual training needs working closely with CSPV management and other business functions as applicable. Oversees the management and maintenance of Onboarding New Hire Training.
- Training Plan and Delivery: Guides instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff as needed. Oversees training compliance and drives optimal training quality conducted within CSPV. Advises on training material, delivery mechanisms, and record keeping.
- Training Records and Maintenance: Partners with Corporate QA to identify training compliance and manages escalation of non-compliance. Actively collaborates with QA LMS Administrator to generate/access necessary training reports and to ensure proper training documentation. Oversees the implementation and maintenance of the CSPV Training Curricula and facilitates modifications with CSPV functional leads. Supports the annual roll-out of the Safety Reporting training assigned to all relevant staff, 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). Identifies and resolves training-related issues. Leads related process improvements as necessary.
Quality and Compliance
- Drives the quality oversight of PV systems to ensure compliance with regulatory requirements and internal corporate/departmental policies and procedures.
- Leads development and execution of meaningful compliance and performance metrics and KPI monitoring system across CSPV key activities.
- Oversees the compilation and aggregation of compliance and performance data and communication of results to CSPV leadership and relevant stakeholders.
- Establishes processes, tools and tracking, and feedback mechanisms for CSPV departmental quality issues identified from compliance and performance monitoring and routine quality assessments.
- Oversees 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.
- Escalates and alerts CSPV leadership and Quality Assurance (QA) of trends and significant deficiencies in quality and compliance standards and initiates issue resolution.
- Leads collaboration with global internal stakeholders, external vendors, and business partners to establish and track CAPAs and implement quality improvement processes and effectiveness checks.
Inspection and Audit Readiness
- Drives an effective system to support the lifecycle of inspections and audits (pre- and post-audit phases) and closely collaborates with Global GxP Audit department in preparation of internal and Business Partner audits and regulatory inspections.
- Leads audit and inspection readiness activities including but not limited to planning and conducting subject matter expert preparation meetings, audit/inspection training, mock interviews; managing audit/inspection communication; facilitating document requests, agendas, interview schedules.
- Actively contributes to corporate and global CSPV inspection readiness initiatives.
- Institutes routine quality assessments to measure preparedness and ensure adherence to company policies and procedures and regulatory requirements.
- Leads analysis of audit and inspection findings, recommends robust remediation plans, and facilitates CAPA responses to closure.
- Collaborates with members of inspection team including GxP Audit and PV-QA to ensure optimal responses to audit/inspection findings.
- Serves as the SME for quality, compliance and training during audits/inspections.
Procedural Document Management
- Procedural Document Program: Lead role in the design, development, and strategic planning of procedural document management activities including the creation, review, and revisions of controlled documents and procedures.
- Procedural Document Development and Delivery: Oversees the management of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates). Actively collaborates with CSPV management, SMEs and other functions to develop or revise SOPs, SOIs and guidance documents and ensures adequate input from business functions. Drives global harmonization of procedural documents to ensure clarify of content, consistency in application, and compliance with applicable policies and regulations. Actively contributes to corporate and departmental initiatives related to procedural document management.
- Procedural Document Records and Maintenance: Provides strategic direction on documentation management including retirement schedules, file structures, and delivery mechanisms. Identifies and resolves procedural document-related issues. Leads related process improvements as necessary. Oversees the implementation of inspection readiness activities related to procedural document management.
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)
- Must have a bachelor's degree preferably in healthcare or life sciences
- Master's Degree preferred
- PharmD preferred
- RN preferred
- 4+ years of pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required or
- 7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development required
- 4+ years' experience in pharmacovigilance training management/lead role in global setting
- Must possess strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines
Ability to travel up to 5% -- up to 2 weeks per year
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.