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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

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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.\nThe Pharmacovigilance and Risk Management (PVRM) Associate Director serves as the PVRM point of contact for cross-functional, global development, and strategic partnership co-development teams while leading safety surveillance activities, including signal detection, evaluation, and risk management activities and ensuring adherence to safety governance for assigned compounds/products. This role will report to the Director, Pharmacovigilance and Risk Management (PVRM).\nJob Duties and Responsibilities

Supports Drug Safety Physician’s Safety Governance efforts by leading cross-functional Safety Management Team (SMT) assessing drug safety profiles and providing safety guidance and input to key safety documents, including IBs, ICFs, protocols, study reports, regulatory reports, and responses to regulatory requests.\nLeads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information through established safety governance.\nMaintains continuous monitoring and updates of safety profiles for assigned investigational and marketed products and ongoing risk/benefit assessment for investigational/marketed products.\nServes as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments. Represent PVRM at cross-functional Steering Committee meetings or corporate partner-related meetings - Joint Safety Forums (JSFs) and PVC.\nPerforms Review of adverse event reports, including but not limited to all serious events of interest, and expedited individual case safety reports, ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment on individual and aggregate levels. Generates or assists with input to Analysis of Similar Events, if required.\nPerforms review of coding (e.g., reaction, suspect/concomitant product, indication, laboratory data, medical history). Provides support for investigator brochures, protocols, informed consent, final study reports, and other safety-relevant documents as appropriate.\nLeads early identification of safety issues that require Safety Governance escalation from Safety Management Teams (SMTs) to Therapeutic Area Safety Committees (TASCs) and/or the Executive Safety Committee (ESC). Serves as SMT Chair/Quorum member for assigned products.\nServes as subject matter expert in study protocol design, review of interim reports for ongoing clinical trials, clinical study reports, safety summary documents, and responses to regulatory requests.\nPrepares and may present individual case safety report issues, aggregate data analyses and interpretation, strategies for submission documents such as the ISS and SCS, and proposed risk mitigation strategies for discussion at internal meetings.\nProvides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development, and updates/maintenance of expectedness guides.\nWork collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.\nReview Literature search strategy and perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities.\nParticipate in aggregate safety report activities, including data compilation and analysis, as well as the writing of assigned sections (with vendor support).\nCoordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests.\nServe as a subject matter expert in PVRM within the assigned program(s) as well as the larger SMPA organization (R&D and Commercial). Other Activities may include, as requested:\nDevelop Standard Operating Procedures, Work Instructions, and other controlled documents.\nContribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.\nSupport collaboration with external partners.\nSupports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of “Patient First” in line with SMPA’s values and related behaviors.\nKey Core Competencies

Proven ability to investigate and resolve complex safety-related issues and make/evaluate proposals for appropriate corrective action.\nGood understanding of global drug safety dynamics and experience with risk mitigation strategies preferred.\nExperience with FDA/EU and/or other regulatory agencies, preparing safety reports for health agencies and authorities both domestically and globally.\nDemonstrated skills working within a matrix environment.\nAbility to work collaboratively with others within and external to the company.\nStrong communication skills with excellent written and spoken English.\nAbility to work independently and productively and set priorities across multiple projects with little supervision.\nExcellent interpersonal skills with demonstrated ability to work in a multi-disciplinary setting and foster teamwork.\nDemonstrate coaching skills to develop the team as appropriate.\nPresentation skills.\nEducation and Experience

Minimum 8+ years of Pharmacovigilance and Risk Management experience required.\nPrior oncology industry experience preferred.\nExperience with early phase development preferred.\nExperience working on a fasted paced dynamic environment.\nPrior leadership or project management experience strongly preferred.\nThe base salary range for this role is $155,000 to $193,800. 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.\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.\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.\nMental/Physical Requirements

: Fast paced environment handling multiple demands. 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.\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 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) 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 reasonableaccomodations@us.sumitomo-pharma.com\nThis contact information is for accommodation requests only and cannot be used to inquire about the status of applications.\nSMPA may use Artificial Intelligence (\"AI\") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.\nAt Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.\nOur

Mission\nTo broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide\nOur

Vision\nFor Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

#J-18808-Ljbffr\n","Overview

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America...","Associate Director, Pharmacovigilance Scientist","Washington, District of Columbia, us, 20022",["B","2517272076"],"9 days ago","/jobs/2517272076-associate-director-pharmacovigilance-scientist","/jobs?location=Washington%2C+District+of+Columbia%2C+us%2C+20022","/jobs?keyword=Associate+Director%2C+Pharmacovigilance+Scientist",{"_429":428,"_434":522,"_452":453,"_444":523,"_243":438,"_441":438,"_427":428,"_111":524,"_431":432,"_433":194,"_454":453,"_442":443,"_425":525,"_455":526,"_430":115,"_476":527,"_460":528,"_478":524,"_479":443,"_481":529,"_483":484,"_485":530},["D",1771286400000],"META","Director of Sanctions Compliance",["B","2619519444"],"Work at META","2 days ago","/jobs/2619519444-director-of-sanctions-compliance","/jobs?keyword=META","/jobs?keyword=Director+of+Sanctions+Compliance",{"_429":428,"_434":532,"_452":453,"_444":533,"_243":438,"_441":438,"_427":428,"_111":534,"_431":432,"_433":194,"_454":453,"_442":443,"_425":535,"_455":536,"_430":115,"_476":527,"_460":537,"_478":534,"_479":443,"_481":538,"_483":484,"_485":539},["D",1771286400000],"CBRE","Director of Global Employment Compliance",["B","2619546170"],"Work at CBRE","/jobs/2619546170-director-of-global-employment-compliance","/jobs?keyword=CBRE","/jobs?keyword=Director+of+Global+Employment+Compliance",{"_429":428,"_434":541,"_452":453,"_444":542,"_243":438,"_441":438,"_427":428,"_111":543,"_431":432,"_433":194,"_454":453,"_442":443,"_425":544,"_455":545,"_430":115,"_476":546,"_460":547,"_478":543,"_479":443,"_481":548,"_483":484,"_485":549},["D",1771113600000],"Arnold Ventures","Director of Infrastructure, Housing",["B","2619512479"],"Work at Arnold Ventures","4 days ago","/jobs/2619512479-director-of-infrastructure-housing","/jobs?keyword=Arnold+Ventures","/jobs?keyword=Director+of+Infrastructure%2C+Housing",{"_429":428,"_434":551,"_452":453,"_444":552,"_243":438,"_441":438,"_427":428,"_111":553,"_431":432,"_433":194,"_454":453,"_442":443,"_425":554,"_455":555,"_430":115,"_476":477,"_460":556,"_478":553,"_479":443,"_481":557,"_483":484,"_485":558},["D",1771372800000],"Humana","Director of Medical Payment Integrity",["B","2621365094"],"Work at Humana","/jobs/2621365094-director-of-medical-payment-integrity","/jobs?keyword=Humana","/jobs?keyword=Director+of+Medical+Payment+Integrity","actionData","errors"]