Manager, PVRM

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 womens 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 or follow us on LinkedIn.

The Safety Scientist Manager is responsible for providing pharmacovigilance and risk management support for assigned products across their lifecycle. This role works collaboratively with Pharmacovigilance (PV) Medical Safety and crossfunctional stakeholders to manage the benefitrisk profile of products ensure patient safety and support regulatory compliance. The position contributes to signal detection aggregate safety reporting safety governance forums and inspection readiness activities while serving as a subject matter expert within the assigned program(s).

Job Duties & Responsibilities

BenefitRisk & Safety Surveillance

• Work collaboratively with PV and crossfunctional team members to manage the benefitrisk 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 and ongoing safety surveillance activities.

Aggregate Safety Reporting

• Participate in and lead aggregate safety report activities including data compilation analysis and writing of assigned sections with vendor support as applicable.

• Ensure highquality accurate and inspectionready contributions to periodic and ad hoc safety reports.

Safety Governance & CrossFunctional Engagement

• Compile agendas data presentation materials and meeting minutes in collaboration with the Program Safety Lead for crossfunctional Safety Management Team (SMT) meetings.

• Represent PV Operations on crossfunctional program and project teams and support PV Medical Safety activities as required.

Ad Hoc Safety Issues & Regulatory Interactions

• Coordinate responses to ad hoc safety issues and inquiries from regulatory authorities clinical sites or healthcare professionals in collaboration with PV physicians.

• Manage internal and crossfunctional communications data requests and compilation of analyses and responses related to safety issues.

Inspection Readiness & Operational Excellence

• Contribute to departmental and crossfunctional inspection readiness activities audits and health authority inspections.

• Support operational improvement initiatives and continuous process enhancements within PVRM and across functions.

Subject Matter Expertise & External Partnerships

• Serve as a subject matter expert in pharmacovigilance including both operational and medical safety aspects for assigned programs.

• Support collaboration and safety oversight activities with external partners and vendors as applicable.

Knowledge Skills and Abilities:

Scientific Regulatory & Technical Knowledge

• Strong working knowledge of pharmacovigilance and risk management principles across the product lifecycle from early development through postmarketing.
• Demonstrated ability to investigate assess and resolve safetyrelated issues including contributing to signal evaluation benefitrisk assessment and identification of appropriate risk mitigation strategies.
• Solid understanding of global drug safety regulations and guidelines including FDA EMA/EU ICH GVP and applicable local regulations; experience supporting preparation and review of safety reports and regulatory responses.
• Ability to critically interpret clinical postmarketing and literature safety data and apply sound scientific judgment in collaboration with Drug Safety Physicians and crossfunctional partners.
• Knowledge of core pharmacovigilance processes including signal detection aggregate reporting safety governance activities and inspection readiness.

Collaboration & Matrix Effectiveness

• Demonstrated ability to work effectively in a matrix environment collaborating with Clinical Development Regulatory Affairs Biostatistics Data Management Quality and external partners.
• Strong interpersonal and teamwork skills with the ability to build productive working relationships across functions and organizations.
• Comfortable representing PVRM on crossfunctional teams and contributing safety expertise to support programlevel objectives.

Communication & Professional Skills

• Strong written and verbal communication skills with the ability to clearly convey scientific and safetyrelated information to diverse audiences.
• Capable of preparing and reviewing clear concise and inspectionready safety documentation presentations and meeting materials.
• Demonstrates professionalism sound judgment and the ability to incorporate feedback and differing perspectives.

Execution ProblemSolving & Personal Attributes

• Strong analytical problemsolving and criticalthinking skills including the ability to manage evolving safety information and regulatory expectations.
• Highly organized and detailoriented with the ability to manage multiple tasks and priorities with minimal supervision.
• Ability to work independently while remaining aligned with team objectives and established processes.

Education & Experience Requirements:

• Minimum of bachelors level degree in a health care/life science related field.
• Masters or other graduate degree preferred.
• Minimum 4 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.

The base salary range for this role is

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.

Confidential Data: All information (written verbal electronic etc.) that an employee encounters is considered confidential in accordance with applicable law.

Compliance: 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.

It 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.

Mental/Physical Requirements:

Fast-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.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field manufacturing or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) 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 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.

Sumitomo 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 . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.