Manager, CTSA, PVRM

About the role

Sumitomo Pharma America, Inc., a U.S. subsidiary of Sumitomo Pharma Co., Ltd., is seeking a Manager, Compliance Training & Strategic Alliance (CTSA), Pharmacovigilance & Risk Management (PVRM). The Manager reports to the Senior Director, CTSA, PVRM, and provides operational oversight of clinical trial safety activities and supports post-marketing pharmacovigilance operations across the company’s development and commercial product portfolio. The role partners with 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.

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.

Requirements

• 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.

Skills

• 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.

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.

Pay

The base salary range for this role is $127,900.00 – $159,900.00. Base salary is part of a total rewards package which also includes merit-based salary increases, short incentive plan participation, eligibility for a 401(k) plan, medical, dental, vision, life and disability insurances, and leaves provided in line with your work state. Total compensation, including base salary, will depend on candidate experience, skills, education and other factors permitted by law.

Benefits

• Opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for 401(k) plan.
• Medical, dental, vision, life and disability insurances.
• Robust time-off policy including 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.