Title:  RAPV Associate, Vietnam

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About Astellas 

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. 

Are you driven to make a real difference in the lives of patients? 

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.

Working Environment and Location

• 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.

Working Hours

Purpose and Scope

Temp Contract (8 months)

Pharmacovigilance (90%)

In close coordination with the RAPV Affiliate Lead, this role is responsible for:

• Execution of the affiliate PV strategy, planning and objectives.
• 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.

Quality Assurance (10%)

• 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.
• Support QA Responsible in Astellas Vietnam to perform the QA activities below:
• Perform Quality Assurance activities on behalf of the Affiliate in its capacity as importer
• Ensure all Astellas products, personnel and third parties conform to local and company quality assurance requirements
• Ensure implementation and maintenance of a Quality Management System, which is compliant with GSP Guidelines, local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of importation undertaken by or on behalf of the affiliate.
• Maintain independence with regards to QA decision making within the affiliate.

Role and Responsibilities

Pharmacovigilance responsibilities include, but are not limited to, the following:

• High-quality PV record management.
• Assisted in maintaining local procedures to ensure adherence to applicable PV requirements.
• Provides adequate PV training as required.
• Effectively works cross-functionally to ensure compliant and up-to-date PV-related contractual arrangements.
• Adequately collects and manages product safety information from all applicable sources and ensures that the Global Safety Database (GSD) is used to record source information accurately, timely and completely at affiliate level. Maintains effective oversight of local / regional / global suppliers that manage this activity permanently or temporarily.
• Distributes and/or submits ICSRs to relevant destinations, as applicable.
• Periodically reviews local literature, as applicable.
• Distributes / submits aggregate reports such as Periodic Safety Update Reports (PSURs) to Competent Authorities (Cas) and Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings (LLs) to Investigators, as required. Manages local translations and creation of annexes and cover letters where required.
• Distributes / submits Risk Management Plans, where required with local translations and cover letter.
• Creation and maintenance of L-RMPs as applicable.
• Adequately and timely implements additional Risk Minimization Measures, as applicable.
• Manages local signal detection- and management-related activities.
• Ensures timely and compliant management of locally required post-authorization studies, as applicable.
• Ensures effective PV business continuity arrangements and PV-related third party life-cycle management.
• Support PV system audits, inspections and management of non-conformances and Corrective Actions and Preventive Action (CAPA) plans.
• Collaborate to appropriately handles potential safety issues as well as timely communication of information that requires notification to local Health Authorities and timely responses to local Health Authority requests.
• Ensures up-to-date content for the (L-)PV System Master File (PSMF).

Continue:Role and Responsibilities

Quality Assurance

As the back-up QA manager in Astellas Vietnam, support to QA responsible to oversight of the implementation and administration of a comprehensive Pharmaceutical Quality System at Astellas Vietnam in order to maintain the state of GMDP compliance.

Support QA Responsible in Astellas Vietnam to perform the QA activities below:

• Support develop and maintain Quality Management Systems (QMS) for deviation management, complaint handling, change control, 3rd party management, annual product review, quality agreements, quality audit, risk management, recall, management review and document controls including procedures and executed GMDP relevant records.
• Support QA responsible for contribution to the development and implementation of 1 – 3 year Global and Local affiliate QA objectives and plans as part of the overall QA strategy and plans.  Participates in the successful execution and implementation of Global QA vision, mission, objectives and plans, if needed. 
• Support to release products to local market of Vietnam by reviewing relevant documents for quality and regulatory compliance.
• Support to ensure implementation and periodic delivery of GMP/GDP compliance training to Affiliate QA, local management team and all staff performing activities with impact on product quality.
• Support QA responsible to manage 3rd parties such as LSPs (Logistics Service Provider) by conducting quality audit, periodic risk assessment and Business/Quality Review meetings.
• Support to establish QA KPIs, including verification of KPI report, and present metrics and quality issues as part of Affiliate Management reviews with senior management of Astellas Vietnam.
• Support to ensure GDP compliance of Affiliate Vietnam owned warehouse by conducting self-inspection, temperature mapping and monitoring, and pest control etc.
• Other tasks delegated/assigned

Essential Qualifications

• Bachelor’s degree (or higher degree) of Pharmacy or related major (Pharmacist preferred. MS degree preferred)

Preferred Qualifications

• At least 1 year’ experience in Pharmacovigilance function and/or Quality Assurance (QA) or regulatory Affairs (RA) function.
• Self-disciplined
• High level of integrity and good morals 
• Excellent customer service skills addressing the needs of internal customers with strong communication and process skills, problem solving, leadership skills, decision making skills, analytical skills, integrity 
• Good English communication skills (verbal and written) 
• Have sound knowledge about products and regulations
• Build teamwork and co-operation spirit
• Open-minded and approachable
• Results orientated and energetic - drives self and others to achieve and/or exceed targets for the benefit of the organization.

Benefits

Careers | Astellas

Salary Range

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
  
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. 
  
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors 

Values: Integrity, Innovation and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

Our Organisational Values and Behaviours

Skills and Capabilities