General Information

Job Advert Title
Sr. Manager PV Scientist
Location
Netherlands
Function/Business Area
Medical & Clinical
Department
Medical Specialities
Employment Class
Permanent

Description

Senior Manager PV Scientist


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


As a key member of the PV Product Responsible team for his/her assigned products, and under the close supervision of the [Associate] Medical Director-level Product Responsible Person (PRP) the PV Scientist (PVS) will:


  • Assist the PRP in coordinating medical-scientific monitoring and assessment of the safety profile of one or more Astellas products. 
  • Assist the PRP with the preparation of meeting materials/presentations for cross-functional meetings such as but not limited to:
  • Product Responsible Teams
  • Core Clinical Development and Core Medical Teams
  • Global Development Safety Management Teams
  • Joint Safety Management Teams
  • Core Teams (Extended)
  • Global Medical Affairs Core Medical Team 
  • The PVS may also, as requested, attend these meetings with the PRP.
  • The PRP owns the strategic priorities and drives implementation, while the PVS supports and contributes as necessary applying knowledge of Therapeutic Area, regulatory science, and signal surveillance to manage characterization of the compound/product safety & benefit-risk profile. These activities will include, but not be limited to: 
  • Supporting the PRP in driving projects forward by active participation within a global matrix.
  • Supporting the PRP in the development of the initial safety surveillance development strategy and leading subsequent updates to this strategy.
  • Performing the first level safety signal detection and signal evaluation activities (e.g., safety database and literature review, health authority queries) for Astellas products, and finalizing these assessments in conjunction with the PRP
  • Support PRP in audits/ inspections and/or CAPA commitments. 
  • Provide guidance and support to Medical Writing vendor staff, in partnership with the PRP, in developing key deliverables by actively participating in working sessions to create timely deliverables, share perspectives, and suggest improvements such as: 
  • Working closely with the PRP and vendor, support risk management activities of assigned products, including preparation of the Risk Management Plans (RMP) and execution of risk management strategies in collaboration with internal and external stakeholders.
  • In collaboration with the PRP, support vendors in the preparation of signal and risk evaluation discussion sections of PSUR, DSUR and PADERs.
  • Draft revisions of RSI section and expected events list for the IB in conjunction with risk evaluation during DSUR preparation and/or signal evaluations.
  • Responsible for the preparation of AOSE reports for IND SUSAR submission to the FDA.
  • Ensure the accuracy, quality, and timeliness of all assigned responsibilities and tasks
  • Assist with data requests, document preparation and/or review of data.
  • If requested, support the Project Coordinator with activities such as meeting scheduling, meeting minutes, and tracking of adherence to deliverables.


Essential Knowledge & Experience


  • Bachelor's degree with related health science background preferred or clinical pharmacy experience strongly preferred. Candidates lacking the preferred experience or appropriate Bachelor’s degree but with previous pharma experience may be considered.
  • Some PV experience or associated field (i.e., regulatory, clinical development, medical affairs), or relevant clinical practice (e.g., pharma/post-pharma fellowship) experience preferred, but not required. 
  • Understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
  • General understanding of safety signalling activities.
  • Competence in safety surveillance analysis and presentation, both orally and in writing.
  • Must be proficient with technology (Windows, Word, Excel, Outlook, PowerPoint).  Proficiency in MS Teams and SharePoint desired.
  • Proficiency in English language, both oral and written, to support working in global environment
  • Ability to communicate and present ideas both orally and in writing.


Additional information:


  • Currently this position has the flexibility to work from home and in the office.
  • This position is based in 
    Leiden in the Netherlands or in Addlestone in the UK
  • Full time.


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.