General Information

Job Advert Title
Associate Director PV Scientist
Location
Netherlands
Function/Business Area
Medical & Clinical
Department
Medical Specialities
Employment Class
Permanent

Description

Associate Director 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


The purpose of the PV Scientist role is to support the Product Responsible Person (PRP) with primary responsibility for signal detection and case series data analysis under the guidance of the PRP.

Assist the PRP in the coordination of medical-scientific monitoring and assessment of the safety profile of one or more Astellas products

Participate and/or act as a delegate and provide input as needed to support the PRP with tasks that may include the preparation and/or presentation of meeting materials/presentations, as appropriate, for PV product 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)
  • And 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:
  • Driving projects forward in partnership with the PRP, while working 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
  • Training and mentoring Jr. PVS on core responsibilities for the PVS role.
  • In partnership with the PRP, the Sr. PVS will lead the signal management activity (i.e., signal tracking, evaluating safety data, leading review meetings, etc.) for assigned product(s) and contribute to the implementation of safety surveillance strategies, weekly literature review for Astellas products and signal identification and evaluation, including SER development.
  • In partnership with the PRP, provide guidance and support to Medical Writing vendors in developing key deliverables by actively participating in working sessions to create timely deliverables, share perspectives, and suggest improvements.  Sr. PVS will support activities such as: 
  • Working closely with the PRP and vendor, contribute to 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.
  • Collaborate with the vendor and contribute to the preparation of the relevant signal and risk evaluation sections of the PSUR, DSUR and PADERs.
  • Support medical writing in the preparation of periodic and ad hoc (e.g., Health authority requests) safety reports for assigned products in terms of contributing to sections and aiding the PRP in drafting/authoring these sections.
  • 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 accuracy, quality, and timeliness of all assigned responsibilities and tasks.
  

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.
  • Significant Pharmacovigilance experience or associated field (i.e., regulatory, clinical development, medical affairs) or relevant clinical practice experience is required. 
  • Understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
  • Competence in safety surveillance analysis and presentation, 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
  • Skills in managing/overseeing people.

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.