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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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 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.
Responsibilities
Quality and Compliance:
Training Program Management:
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)
Experience Qualifications
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.
br{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Location: Kansas City, MO Job_Code: 5651 # of Openings: 1 Job Brief Remote Opportunity Agile...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> JOB DESCRIPTION A worldwide leader in transportation infrastructure construction and maintenance is seeking a Remote...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Come grow with us! Maxor is currently seeking an IT Support Analyst with Pharmacy Technician...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Salary: $65 – 75 per hour Reference: JOB-6602-C Locus is a nimble, experienced consulting team...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Who is Recruiting from Scratch: Recruiting from Scratch is a premier talent firm that focuses...
Apply For This JobAt Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s...
Apply For This Job