Pharmacovigilance Scientist (Associate Director)

Astellas; Markham; Hybrid; CAD 70,000 - 110,000; Full time

Job summary

Join an innovative team dedicated to developing therapies that improve patient outcomes. As a PV Scientist, you will play a crucial role in analyzing safety data and supporting the strategic direction of product safety. This position offers the chance to work collaboratively within a global matrix, ensuring that innovative solutions are effectively communicated and implemented. Your contributions will directly impact the quality and safety of products that enhance the lives of patients worldwide. Embrace the opportunity to make a meaningful difference in the healthcare landscape while working in a supportive and inclusive environment.

Qualifications

• Experience in pharmacovigilance and safety signal detection.
• Strong analytical skills and attention to detail.

Responsibilities

• Assist in monitoring and assessing safety profiles of products.
• Support the PRP in safety signal detection and evaluations.

Skills

Signal Detection

Data Analysis

Regulatory Science

Risk Management

Medical Writing

Education

Bachelor's Degree in Life Sciences

Advanced Degree (Master's or PhD)

Tools

Safety Databases

Statistical Software

Job description

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop 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 Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity 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 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.

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.

ReqID: 25-POS00069873M