Job Information
Daiichi Sankyo Inc. Manager, Global Pharmacovigilance Quality in Basking Ridge, New Jersey
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
Support the PVQA quality strategy and quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, Managed Access programs and Collaborative Research to the highest quality standards globally end-to-end end to end proactive quality support across programs ensuring GCP, GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required.
Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs programs, e.g. interact with stakeholders for prompt identification and resolution of Quality Events; timely escalation of incidents/issues; oversight for deviations/incidents & investigations, 3rd party/vendor oversight and liaison to support audit and inspections as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted business functions.
Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including timely escalation of critical issues, tracking of timely closure, and proper effectiveness checks. Support lessons learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards, policies and procedures through partnership with stakeholders and QA line functions.
Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and the tracking of Key Quality Indicators (KQI) (e.g. Quality Plan status, metrics, trends in deviations and Quality Events, inspection/audit findings, inspection/audit CAPAs). Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted business functions. Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including timely escalation of critical issues, tracking of timely closure, and proper effectiveness checks. Support lessons learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics.
Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards, policies and procedures through partnership with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance and the tracking of Key Quality Indicators (KQI) (e.g. Quality Plan status, metrics, trends in deviations and Quality Events, inspection/audit findings, inspection/audit CAPAs).
Responsibilities
- Leadership/ Program oversight :
Support the quality strategy and/or quality plan closely aligned with specialty and the Oncology Business Unit Strategy globally; promote a quality culture by providing study team support to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, Managed Access programs and Collaborative Research to the highest quality standards globally.
Support end to end proactive quality support across programs ensuring GCP, GPV, GDP and other local requirements are adequately considered in the planning and conduct of Interventional, Non-interventional, Managed Access Programs, Investigator initiated studies and Collaborative Research.
Support adherence to regulatory safety requirements for all programs (i.e. post marketing, MAA requirements, Company Sponsored Interventional Program SAE reporting, SUSAR distribution).
Support the importance of Medical Affairs programs as essential to promote the value of marketed products and ensure ongoing compliance to Health Authority requirements and expectations to support label extension, ongoing submissions as well as Managed Access programs which allow access to unapproved medicines for patients with unmet medical needs.
- Quality Management and Continuous Improvement:
Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including tracking of timely closure, proper effective checks and adequate and timely escalation of critical issues.
Support lessons learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics.
- Cross-functional and Global Team Participation :
Proactively collaborate with other GxP quality representatives and act as the QA point person for US and EU Medical Affairs programs, e.g. interact with subject matter experts for prompt identification and resolution of issues and safety reporting requirements across Medical Affairs activities: Interventional studies, Non-interventional studies, Compassionate Use or Managed Access Programs, Investigator initiated studies and Collaborative Research to include timely escalation of Quality Events, oversight for investigations, 3rd party/vendor oversight and liaison to support audit and inspection as applicable.
- Customer Focused/ stakeholder engagement :
Support interpretation of regulations and company process standards, guidelines, policies and procedures to personnel specifically for assigned programs or for continuous improvement projects.
Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including liaising with functional representatives to ensure timely closure of CAPAs, proper effective checks and adequate and timely escalation of critical issues.
- Regulatory Inspections:
Support inspections with adequate systems and process support; ensure timely and effective preparation and management of HA inspections, including facilitation of respective regulatory inspection preparation and management and follow-up in collaboration with relevant business functions.
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 in Life Sciences, Pharmacy or Medicines required or
Master's Degree or other advanced degree preferred
Experience Qualifications
Eight (8) plus years of pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in a regulated GCP environment or equivalent experience preferred
Experience in Clinical Safety and Pharmacovigilance preferred
Medical Affairs experience preferred
Travel
Ability to travel up to 20%
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.