General Information

Job Advert Title
Manager Data Assurance
Location
Netherlands
Function/Business Area
Legal, Risk, Ethics & Compliance
Department
PV Case Management
Employment Class
Permanent

Description

Manager Data Assurance


About Astellas:


At Astellas, we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About This Job:


Responsible for development and maintenance of excellence in Data Assurance, with a focus on operational aspects of individual case safety report (ICSR) and literature global standards and drives quality, consistency and operational efficiency across the Astellas PV Case Management functions, regions and case processing vendor(s).

Reports to the Data Assurance Team Lead is a member of the Data Assurance Management Team and contributes to the development, implementation, and successful execution of the PV objectives and 1-3 year operational plan, supporting the overall PV Case Management and PV mission.

Responsible for ensuring the quality of (contracted) work delivered under the PV Case Management and regional function, which directly impacts the effective management of the safety profile of Astellas development compounds and marketed drugs.

Leads the regional Data Assurance team ensuring high-quality operational data and a variety of QC and training activities associated with ICSR and literature processing.

Works extensively with vendor personnel and PV Case Management staff within and across the regions to ensure the high data quality required to support the ongoing assurance of the safety profile of Astellas products.

Supports inspection readiness activities and fulfils the role of a key SME for topics associated with in-house and outsourced operational case safety aspects of PV Case Management activities for case processing, literature search and assessment.


Essential Knowledge & Experience:


  • Minimum BA/BS, preferably with an advanced professional degree
  • Minimum 5 years of relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development, including extensive leadership experience, including ability to lead and manage a global, multidisciplinary teams
  • In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations
  • In-depth knowledge and understanding of ICSR processing regulatory requirements and guidelines in assigned region
  • Proven experience with establishing and maintaining (GxP) Qualities Management System.
  • In-depth personal experience and understanding of Process Management, Standards &Training as they apply throughout the entire pharmaceutical compound/product life cycle

Preferred Knowledge & Experience:


  • Demonstrates leadership to ensure case processing, (medical) evaluation and case quality are maintained to the highest standards at all times
  • Demonstrates effective leadership and management skills, including the ability to lead and manage a multidisciplinary team
  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus on medical matters and able to develop effective relationships through collaboration.
  • Demonstrated ability to resolve conflict situations, think tactically, and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and fun level.
  • Able to lead meetings, present orally and interact with external bodies
  • Excellent communication and presentation skills in English (written and spoken)
  • Ability to leverage all available resources internally and externally

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law