Manager, PVRM

Overview Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned program(s). Ability to work collaboratively with cross-functional colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. Responsibilities Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety. Assist in signal detection activities including data assembly, signal validation, and signal evaluation. Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities. Participate and lead aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.) Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings. Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required. Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results. Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities. Collaborate with Clinical Development to interpret safety data from ongoing clinical trials. Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program. Support collaboration with external partners. Key Core Competencies Strong understanding of pharmacovigilance regulations and drug safety reporting requirements Skills in signal detection, risk assessment, and safety data analysis Proficiency with safety databases and software Ability to evaluate and write case reports and prepare regulatory submissions Analytical thinking and attention to detail Communication skills for cross-functional collaboration and regulatory interactions Project management and organizational abilities Ability to work effectively within teams Additionally, experience using tools such as Argus, Oracle, MedDRA, Empirica, and Excel is highly valuable for this position Education and Experience Minimum of bachelor’s level degree in a health care/life science related field, with Master’s or other graduate degree preferred. Minimum 3 years’ experience within Pharmacovigilance and in the pharmaceutical industry. Prior experience in oncology, and/or neurology is strongly preferred. Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. Compensation and Benefits The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. EEO : Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, affectional or sexual orientation, disability, veteran or military status or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. #J-18808-Ljbffr