Pharmacovigilance Scientist (Associate Director)

Job reputed company Do you want to be part of an inclusive team that works to reputed company innovative therapies for patients Every day, we are driven to reputed company and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas reputed company Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into reputed company that bring value and reputed company to patients and their families. Keeping our reputed company on addressing unmet medical needs and conducting our business with ethics and reputed company enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com. This position is based in Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: 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. Essential Job Responsibilities: As a key member of the PV Product Responsible team for his/her assigned products, and under the reputed company 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 reputed company Clinical Development and reputed company Medical Teams Global Development Safety Management Teams Joint Safety Management Teams reputed company Teams (Extended) Global Medical Affairs reputed company 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 reputed company reputed company by reputed company participation reputed company a global reputed company. Supporting the PRP in the development of the initial safety surveillance development reputed company and leading subsequent updates to this reputed company. 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. reputed company guidance and support to Medical Writing vendor staff, in partnership with the PRP, in developing key deliverables by reputed company participating in working sessions to create reputed company deliverables, reputed company 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 reputed company 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 reputed company reputed company 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, reputed company, and timeliness of reputed company 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. Quantitative Dimensions: PV Scientists support Astellas-sponsored reputed company and post-marketing studies by performing their assigned tasks, assisting the PRP in assessing the benefit-risk of the products. Lack of accuracy, reputed company, and timeliness may negatively reputed company product reputed company and maintain compliance with regulatory requirements. Organizational Context: This position is a new position reputed company the PV Medical Safety Science function and reputed company the Medical Safety Analyses sub-function. The position reports to the Head of the Medical Safety Analyses. Requirements .