Job Title

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 . **This position is based in Mexico, Mexico City. Purpose & Scope: Global Safety Officer is accountable for proactive safety surveillance of Astellas drug products, both those in development and marketed products, including leading PV Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile and responsible for the design and successful implementation of signal management and risk management strategies for assigned products. Essential Job Responsibilities: Leads PV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participates in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimalbenefit-risk profile. Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator’s Brochure and local product labeling. This also includesresponsibility for effectiveand regular communication with the Global TA Group Lead and with the applicable QPPV. Responsible and accountable for the designof safety surveillance strategies, management of safety signals for Astellas drug products, both those in development and marketed products, 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 Safety Science. Responsible and accountable for the risk management of assigned Astellas drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP)and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Safety Science. Responsible and accountable for timely and high quality contribution to periodic and ad hoc (e.g. Health authority requests) safetyreports for assignedproducts 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 as a member of study teams and for representing PV in the design, conduct,analysis and reportingof Phase 1 – Phase 3 clinical trials and Post-Authorization Studies. Qualifications: Required Bachelor's degree required; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical industry experience in a relevant therapeutic area preferred). Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with bachelor’s or master’s degree, in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus. 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 M.D. strongly preferred (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).