Algemene informatie

Job Advert Title
Senior Manager Workflow Management
Locatie
Nederland
Function/Business Area
General Management
Afdeling
PV Case Management
Werkcategorie
Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Senior Workflow Management Manager

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 global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
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:

The Senior Workflow Management Manager reports to Workflow Management Lead and is responsible for the development and maintenance of excellence in the operational strategy of overall workflow management and contributes to comply all requirements in the assigned region, which consists of each step performed by vendors and/or in-house resources. Responsible for overseeing adherence of procedures and conventions which relates safety information operational workflow to ensure pharmacovigilance regulatory reporting compliance and quality. Responsible for developing and implementing excellent strategy for oversight overall workflow management in collaboration with vendors, in-house resources, as well as relevant stakeholders internally and externally in assigned region. Contributes to establish of key metric information and identifies/implements continuous improvement initiatives. Contributes to inspection readiness for topics associated with safety information activites. Works extensively within PV Operations, PV Compliance, Oversight & Process Excellence (PV COPE), PV Systems and Interface Management (PV SIM), Medical Safety Science, EU-QPPV office, JP QPPV, Affiliate Management, Business Partner Management, Drug Safety Officers, and non-PV stakeholders (e.g. Medical Affairs, Medical Science, Development Operations) to ensure strategic alignment with the PV vision and those outputs directly support the ongoing assurance of the safety profile of Astellas products.

Key Activities are noted below:

  • In-depth knowledge and understanding of pharmacovigilance regulatory reporting requirements and guidelines in the assigned region.
  • In-depth understanding of PV adverse event intake, processing, and follow-up activities.
  • Excellent time-management and proven organizational skills.
  • Demonstrates dedication, stamina and leadership to ensure case submission and compliance are maintained at highest standards at all times
  • Demonstrates effective leadership and management skills when maintaining these standards in cooperation with an external vendor
  • Good communication skills to develop effective relationships through collaboration
  • Demonstrated ability to proactively predict and resolve capacity challenges and/or conflict situations, think tactically and generate solutions to complex problems
  • In-depth knowledge of pharmacovigilance processes and operations
  • Able to lead meetings, present orally and interact with external bodies
  • Ability to leverage all available resources internally and externally
  • Good knowledge of pharmacovigilance processes and operations
  • Willingness to be reachable at all times and to work outside normal working hours as required

Experience and Knowledge:

  • Extensive previous industry experience;
  • Extensive experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development.
  • Experience in managing projects in a cross-functional environment.
  • In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH and EU GVP module.
  • Experience with maintaining (GxP) Qualities Management System.

Qualifications:

  • Bachelor’s Degree in science or equivalent.

Additional information:

  • Currently this position has the flexibility to work from home and in the office.
  • This is a permanent full-time position based in the UK or in the Netherlands.

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.