Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in United States or Canada. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The primary focus of this position is to contract and manage resources responsible for assessing processes at Astellas, and any contracted service providers to ensure that systems, policies and procedures comply with national and international requirements for the pharmacovigilance function and the collection and reporting of safety information.
This comprises both auditing as directed, and consultancy activities and related control of cost and financial aspects. This role develops and manages a sub selection of the quality system and operations across region.
As QA Expert, provides QA consultancy (Identifying risk, leading continuous improvement) services to the organization for the Pharmacovigilance and related functions. This role will coordinate the preparation, the conduct and the follow up of Regulatory Inspections as directed.
Essential Job Responsibilities:
Quantitative Dimensions:
Organizational Context:
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