Manager, CTSA, 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, 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.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Compliance Training & Strategic Alliance (CTSA), Pharmacovigilance & Risk Management (PVRM). The Manger reports to the Senior Director, CTSA, PVRM.

The Manager is responsible for providing operational oversight of clinical trial safety activities and supporting post-marketing pharmacovigilance operations across Sumitomo Pharma's development and commercial product portfolio. The role serves as a key partner to Clinical Operations, Clinical Development, Medical Monitoring, Safety Science, Regulatory Affairs, Quality, and external vendors to ensure compliant collection, assessment, processing, reporting, reconciliation, and oversight of safety information throughout the product lifecycle.

The Manager is responsible for study-level safety oversight, management of CROs and pharmacovigilance vendors, compliance monitoring, inspection readiness, and execution of risk-based quality management practices. This role supports both investigational and post-marketing safety activities, drives continuous improvement initiatives, and contributes to maintaining a robust global pharmacovigilance system.

Key Responsibilities:

• Serves as the operational lead for clinical trial safety activities across assigned development programs.

• Provides study-level safety oversight throughout the clinical trial lifecycle, including study startup, conduct, database lock, and study closeout.

• Partners with Clinical Operations, Clinical Development, Medical Monitoring, Safety Science, Regulatory Affairs, and Quality to ensure compliant execution of safety activities.

• Supports identification, escalation, and mitigation of operational safety risks impacting clinical programs.

• Participates in study teams and governance forums, providing expertise on safety operations and regulatory requirements.

• Supports study-level safety governance, inspection readiness, and operational planning activities.

• Manages CROs, pharmacovigilance vendors, and external partners to ensure compliance with contractual obligations, quality agreements, and applicable regulations.

• Monitors vendor performance related to case processing, SAE management, regulatory reporting, reconciliation activities, and compliance requirements.

• Supports both clinical trial and post-marketing safety operations, ensuring quality, timeliness, and inspection readiness.

• Leads investigations, issue resolution, and remediation activities related to vendor performance or compliance concerns.

• Supports governance meetings and performance reviews with internal and external stakeholders.

• Oversees safety data reconciliation activities across clinical systems, safety databases, vendors, business partners, and licensing partners to ensure complete and accurate safety information.

• Develops, monitors, and analyzes clinical trial and post-marketing safety KPIs and KRIs to proactively identify operational risks and compliance trends.

• Performs trend analysis, identifies emerging risks, and implements mitigation plans to support proactive compliance management.

• Ensures adherence to company procedures and global pharmacovigilance regulations throughout the product lifecycle.

• Supports inspection readiness activities for clinical development and post-marketing programs.

• Participates in internal audits, external audits, regulatory inspections, and health authority inquiries.

• Collaborates with Quality and cross-functional stakeholders on CAPAs, root cause investigations, effectiveness checks, and continuous improvement initiatives.

• Maintains inspection-ready processes, documentation, and oversight practices supporting the global pharmacovigilance system.

• Contributes to the development and maintenance of SOPs, work instructions, and operational guidance documents related to clinical trial safety and pharmacovigilance operations.

• Supports implementation of new technologies, process improvements, and organizational initiatives that enhance quality, compliance, efficiency, and inspection readiness.

• Provides subject matter expertise for strategic projects, vendor transitions, system enhancements, and cross-functional initiatives.

• Supports training, onboarding, and knowledge-sharing activities for internal staff and external partners.

Key Core Competencies:

• Ability to work independently and manage multiple priorities in a dynamic, matrixed environment.

• Strong leadership, influencing, stakeholder management, and team development skills.

• Demonstrated strategic thinking, analytical problem-solving, and risk-management capabilities.

• High degree of integrity and commitment to patient safety, quality, and regulatory compliance.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and organizational levels.

• Experience managing vendors, CROs, and external business partners.
• Proficiency in Microsoft Office and relevant pharmacovigilance, clinical trial, and quality systems.

Professional Experience/Qualifications:

• Bachelor's degree preferably in a scientific, healthcare, regulatory, pharmacy, nursing, life sciences, or health-related field.

• Minimum 4 years of experience in pharmacovigilance, drug safety, clinical development, or related regulatory functions.

• Minimum 3 years of experience supporting clinical trial safety operations, including study-level safety oversight, safety reporting, reconciliation activities, or vendor management.

• Experience supporting post-marketing pharmacovigilance activities, including case processing, compliance oversight, aggregate reporting, safety surveillance, or vendor management.

• Demonstrated experience managing CROs, pharmacovigilance vendors, and cross-functional safety programs.

• Strong understanding of global clinical trial and post-marketing pharmacovigilance regulations and guidance, including FDA, EMA, MHRA, PMDA, Health Canada, and ICH requirements.

• Experience supporting regulatory inspections, audits, and inspection readiness initiatives.

• Experience supporting global clinical development programs preferred.

• Strong analytical, problem-solving, communication, and project management skills.
• Demonstrated ability to influence across functions and operate effectively within a matrix environment.

Travel Requirements:

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

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.

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.

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