{"id":3560002,"url":"https://alion.io/job/sumitomo-pharma-senior-manager-pvrm-safety-scientist","title":"Senior Manager, PVRM Safety Scientist","company":{"id":1797163,"name":"Sumitomo Pharma","domain":"sumitomo-pharma.com","url":"https://alion.io/company/sumitomo-pharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Marlborough, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":157000,"max":196300,"currency":"USD","period":"year","gross":null,"usd_annual":196300},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-30T00:00:00Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-04T19:15:42Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.\nSumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company.\nJob Overview\nThe Senior Manager, Pharmacovigilance Scientist serves as a primary Pharmacovigilance and Risk Management (PVRM) point of contact for assigned programs and works collaboratively with cross-functional colleagues, global development teams, and strategic partners. This role leads and supports safety evaluation and risk management activities and ensures appropriate application of safety governance processes for assigned compounds and products.\nJob Duties and Responsibilities\nLead cross-functional Safety Management Team (SMT) meetings and provide safety guidance and input to key documents, including Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses.\nContribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information through established safety governance processes.\nMaintain ongoing monitoring and assessment of safety profiles for assigned investigational and marketed products, supporting continuous benefit-risk evaluation.\nCollaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions. Represent PVRM on cross-functional teams and at partner safety meetings, including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC) meetings, as applicable.\nReview adverse event reports, including serious cases, to support appropriate interpretation, consistency, and quality across individual case and aggregate safety assessments; support Analysis of Similar Events as needed.\nReview relevant clinical coding, including reactions, suspect/concomitant products, indications, laboratory data, and medical history, and support preparation and review of Investigator Brochures, protocols, informed consent documents, clinical study reports, and other safety-related documents.\nFacilitate early identification and escalation of safety issues through established safety governance processes. Serve as SMT Chair or Quorum member as assigned.\nServe as a PVRM subject matter expert in the review of study protocols, interim clinical trial reports, clinical study reports, safety summary documents, and responses to regulatory requests.\nSupport preparation and presentation of individual case safety issues; conduct aggregate safety data analyses and interpretation; contribute to submission documents, including ISS and SCS, and support development of risk-mitigation strategies.\nContribute to the development and maintenance of safety and risk-management documents, including Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and expectedness guides, as applicable.\nWork collaboratively with PVRM and cross-functional team members to manage the benefit-risk profile of assigned products and support patient safety.\nReview literature search strategies and literature monitoring activities, with vendor support, and ensure relevant information is incorporated into signal detection and evaluation activities.\nParticipate in and lead assigned aggregate safety report activities, including data compilation, analysis, interpretation, and preparation or review of assigned sections, with vendor support as applicable.\nCoordinate responses to ad hoc safety issues and requests from regulatory authorities, study sites, healthcare professionals, and other stakeholders in collaboration with appropriate medical and cross-functional colleagues.\nServe as a PVRM subject matter expert for assigned programs and contribute expertise across R&D and Commercial functions.\nDevelop or contribute to Standard Operating Procedures (SOPs), Work Instructions, and other controlled PVRM documents, as assigned.\nContribute to departmental and cross-functional inspection readiness, quality, compliance, and operational improvement initiatives.\nSupport PVRM and cross-functional projects requiring safety input, promote compliance with applicable regulatory requirements and internal procedures, and foster a Patient First culture consistent with SMPA values.\nKey Core Competencies\nStrong understanding of pharmacovigilance, drug safety, benefit-risk assessment, and global safety requirements.\nDemonstrated experience with signal detection, evaluation, and safety data analysis.\nExperience preparing and/or contributing to aggregate safety reports, regulatory submissions, and responses to regulatory authorities, including FDA and EMA and/or other global health authorities.\nAbility to interpret clinical and safety data and communicate safety findings clearly to cross-functional stakeholders.\nDemonstrated ability to operate effectively in a cross-functional and matrixed environment.\nStrong collaboration and relationship-building skills across organizational and geographic boundaries.\nExcellent written and verbal communication skills.\nDemonstrated ability to work independently, manage multiple priorities, and deliver high-quality work with minimal supervision.\nDemonstrated leadership and project-management capabilities.\nEducation and Experience\nMinimum of a bachelor’s degree in a healthcare, life science, or related scientific field; advanced degree preferred.\nMinimum 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.\nRelevant experience in clinical development safety, signal management, aggregate reporting, and/or benefit-risk assessment preferred.\nPrior experience leading cross-functional activities, programs, or projects strongly preferred.\nPrior experience in oncology and/or neurology preferred.\nComprehensive understanding of applicable FDA and EU pharmacovigilance requirements and GCP/GVP/ICH safety guidelines for investigational and marketed products.\nTravel Requirements:\nPrimarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.\nMental/Physical Requirements:\nFast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.\nThe base salary range for this role is\n$157,000.00 - $196,300.00Base 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.\nDisclaimer: 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.\nConfidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.\nCompliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the \"best\" industry practices and the highest ethical standards.\nIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.\nDrug Screening Requirements\nApplicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.\nSumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer\nQualified 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 liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nSumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at . 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