Pharmacovigilance Scientist (Associate Director)

Responsibilities :

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 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

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.

Quantitative Dimensions :

PV Scientists support Astellas-sponsored clinical trials and post-marketing studies by performing their assigned tasks, assisting the PRP in assessing the benefit-risk of the products. Lack of accuracy, quality, and timeliness may negatively impact product success and maintain compliance with regulatory requirements.

Organizational Context :

This position is a new position within the PV Medical Safety Science function and within the Medical Safety Analyses sub-function. The position reports to the Head of the Medical Safety Analyses.

Requirements

Qualifications : Required

Benefits :