Astellas Canada - Global Safety Officer, Oncology At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people. Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation. About Us: We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma. In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments. We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you. From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset. Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas. Astellas Pharma Canada (APCA) is looking to fill vacant position - Global Safety Officer, Oncology. 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. Qualifications Required • Medical doctorate or advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred. In absence of an advanced degree, a minimum of 5 years PV experience required. • Minimum of 7 years of experience in the pharmaceutical industry and/or a relevant health science setting (such as academia); direct experience in PV or clinical development preferred. • In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk. Preferred • Ability to communicate (written and oral) in additional languages (Dutch, Japanese) preferred. Working Environment At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Travel (Domestic or International) into an Astellas Office may be periodically required to support business needs (e.g. Regulatory Inspection, pivotal project/asset team discussions). On-site work is more likely to be required during global Regulatory Inspections. If the position is located in one of the Astellas Global Capability Centers/ countries, on-site work may be required for the first 6 months, until full orientation and training is complete. Following completed training, hybrid working may be allowed, with the number of on-site workdays per week to be discussed with the manager. This is subject to change based on location and business need. Additionally, this position may require work hours that overlap with some of the EU/ US time zone work hours (to be determined based on business need and discussed with your manager). Salary Range: $144,000 - $194,000 CAD annually per year (final compensation will be determined based on a variety of factors, including but not limited to proficiency levels and organizational equity considerations) • The salary range provided applies to Canada only and does not apply to any other locations outside of Canada. Benefits: • Medical, Dental and Vision Insurance • Generous Paid Time Off options, including Vacation, Sick time and national holidays • RRSP Pension • Company paid life insurance • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions • Long Term Incentive Plan for eligible positions • Wellness programs Astellas may use artificial intelligence-enabled tools at various stages of the recruitment and selection process. Additional Information Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process. No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted. #LI-TD Apply tot his job