Manager, Global Pharmacovigilance Quality - Basking Ridge, United States - Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Verified Company
Basking Ridge, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description
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 pr
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