About this role
RAPV Associate, Vietnam
Description
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About Astellas
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Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
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Are you driven to make a real difference in the lives of patients?
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We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
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Working Environment and Location
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This position is onsite in Ho Chi Minh City, Vietnam
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At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas Responsible Flexibility Guidelines.
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Working Hours
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Purpose and Scope
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Temp Contract (8 months)
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Pharmacovigilance (90%)
In close coordination with the RAPV Affiliate Lead, this role is responsible for:
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Execution of the affiliate PV strategy, planning and objectives.
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Compliance with applicable policies / procedures, laws / regulations / guidelines and contractual agreements as well as continuous improvement of the affiliate’s PV Quality Management System, including effective regulatory intelligence and change management.
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Quality Assurance (10%)
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Support QA Responsible for Collaboration in further setup, maintenance, and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of Astellas Vietnam and its third parties.
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Support QA Resp