Associate Director, CTSA, PVRM

Sumitomo Pharma • Marlborough, MA

54d • $155,000 - $193,000

About The Position

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.

Requirements

• 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.
• 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).

Nice To Haves

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

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director