Associate Director, 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.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, CTSA, PVRM.

The Associate Director provides advanced operational leadership and oversight for Pharmacovigilance (PVRM) and non-PVRM vendor management, adverse event handling and reporting, and supporting global PV systems. This role manages vendor relationships to ensure contract compliance and performance and oversees quality control (QC) activities to maintain high standards in PV operations. The Associate Director is also responsible for compliance training, quality monitoring, audit and inspection preparedness, and executes cross-functional initiatives to drive operational excellence and regulatory adherence. The Associate Director collaborates closely with the PVRM Information Management (IM) and Safety Science groups, contributing as a key member of matrix teams supporting PV activities, while supporting strategic initiatives within defined areas of responsibility.

Job Duties and Responsibilities

•             Set vision and direction for PVRM and non-PVRM vendors, ensuring robust contract compliance, performance metrics, and alignment with business goals.

•             Oversee vendor activities, including case processing and safety data management, to ensure timely, accurate, and compliant operations across global regions.

•             Establish and monitor vendor QC expectations, review QC processes and audit outcomes, and implement corrective actions to uphold high standards in safety data management.

•             Lead high-impact initiatives to enhance adverse event (AE) management and reporting, ensuring global regulatory compliance and best-in-class practices.

•             Oversee audit and inspection readiness, championing cross-functional collaboration and driving successful regulatory outcomes.

•             Direct the creation, maintenance, and optimization of standard operating procedures (SOPs) for PV operations and quality systems, ensuring regulatory compliance and operational excellence.

•             Serve as the principal liaison for global safety planning, data collection, and reconciliation, ensuring seamless integration across business units and affiliates.

•             Provide expert guidance, oversight and alliance management support for Pharmacovigilance Agreements (PVAs), including but not limited to development of PVA, implementation, and monitoring of obligations with internal and external partners.

•             Develop and implement advanced PV staff learning and development programs to foster talent growth and organizational capability.

•             Mentor, coach, and develop team members, cultivating a high-performance, inclusive culture in a dynamic, fast-paced environment.

•             Represent the organization in external forums, regulatory interactions, and strategic partnerships.

Key Core Competencies

•             Demonstrated strategic thinking and strong organizational awareness, with the ability to influence and collaborate effectively at all levels of the organization.

•             Advanced leadership, project management, and cross-functional collaboration skills, driving results in complex and dynamic environments.

•             Expertise in mentoring, coaching, and developing high-performing teams to achieve organizational goals.

•             Superior verbal and written communication skills, with the ability to present complex information clearly to diverse audiences.

•             Deep knowledge of US and international pharmacovigilance regulations and industry best practices.

•             Proven ability to manage confidential and sensitive information with discretion, integrity, and sound judgment.

•             Strong customer-service orientation and professionalism, consistently delivering high-quality work products.

•             Ability to thrive and adapt in a fast-paced, dynamic, and rapidly growing environment.

Education and Experience

•             Bachelor's degree preferably in a scientific, regulatory, or health-related field; advanced degree preferred.

•             Minimum 8 years of relevant experience in healthcare industry

•             Minimum 7 years of experience in Pharmacovigilance operations, quality and compliance.

•             Significant experience in project leadership, strategic planning, and global regulatory frameworks (US, EEA, UK, Canada).

•             Prior experience in a senior management or leadership role preferred.

The base salary range for this role is $155,000 to $193,000. 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.

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. 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.

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.