Global Safety Officer, Oncology

Astellas Pharma Canada (APCA) is looking to fill vacant position – Global Safety Officer, Oncology.

 

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

 

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

 

Description

Reporting to the Global Medical Safety Team Lead, the Global Safety Officer (GSO) is accountable for proactive safety surveillance of Astellas drug products, both in development and marketed. As the GSO for his/her assigned Astellas asset(s) and a member of the asset team, the GSO is accountable for the conduct of all medical safety surveillance activities. The GSO also supports the execution of clinical risk management activities put in place to optimize the overall benefit/risk profile.

Essential Job Duties

• Leads PV product responsible teams for assigned products, co-chairs Safety Management Teams, and participates in Asset Teams as the representative of the pharmacovigilance function ensuring the execution of robust medical safety surveillance and risk management activities for his/her assigned products. Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates to the Investigator’s Brochure and Company Core Data Sheet. This also includes responsibility for effective and regular communication with senior management, and with the applicable QPPV.
• Responsible and accountable for the design of safety surveillance strategies, management of safety signals for Astellas products, both those in development and marketed, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with the PV Scientist(s)and other Safety Science functions such as Aggregate Safety Analyses, Signal and Risk Management Officers, among others.
• Accountable for the risk management activities for assigned Astellas products, both those in development and marketed, the development of the Risk Management Plan (RMP). Collaborates with internal and external stakeholders and works closely with the Risk Management Officer in the development and execution of risk management strategies.
• Accountable for timely and high-quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
• Responsible and accountable for the ongoing monitoring and assessment of the safety profile of assigned Astellas developmental and marketed products and for representing PV in the design, conduct, analysis and reporting of Phase 1 – Phase 3 clinical trials and Post-Authorization Studies.

People & Organization Leadership and Management

• Within the RAPV organization, the GSO works effectively with Pharmacovigilance Scientists, Signal and Risk Management Officers, Aggregate Safety Analyses, Business Partner Management, RAPV Operations, the EU and JP QPPVs and the Global/ Regional Regulatory Lead. External to RAPV, the GSO collaborates closely with members of the Asset Team, especially the Development physician/ Medical Lead in Development and the Medical Affairs Lead to lead SMTs/ BRTs and ensure optimal benefit-risk of the assigned products.
• Displays the highest level of personal commitment to the Astellas Code of Ethics. Inspires team members by displaying accountability and holding others accountable for their deliverables. Commits through co-accountability, to function and positive culture within the Asset Team, MS and RAPV.