Senior Manager, Global Case Management

Otsuka • Princeton, NJ

9d

About The Position

The Senior Manager, Global Case Management provides day-to-day operational support, subject matter expertise, and oversight of global Individual Case Safety Report (ICSR) management activities. The role supports effective execution of case processing workflows managed internally and by vendors, ensuring accuracy, compliance, and high-quality deliverables. The Senior Manager works with Clinical, Medical Safety, Data Management, Alliance Management, and other cross-functional partners to support the safety lifecycle and timely case management deliverables.

The role may contribute to regulatory inspections, audits, and continuous improvement by supporting process implementation, addressing operational challenges, and helping maintain inspection readiness. It also provides operational oversight of outsourced case processing, supports staff coverage and training, maintains case management documentation and oversight reports, and collaborates on clinical and postmarketing safety activities. Domestic and international travel may be up to 10% as applicable.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
• At least 3 years of experience in Pharmacovigilance, case management, or related drug safety functions.
• Experience working with global teams or large-scale PV operations.
• Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, CIOMS, and other regional health authority requirements.
• Experience working with an outsourced PV model.
• Experience supporting inspections and participating in audits, including presenting, responding, and leading remediation efforts.
• Proficiency with safety databases, intake tools, and related PV systems.
• Experience supporting clinical trial safety and postmarketing PV activities.
• Experience in a global matrixed organization.
• Domestic and international travel up to 10% as applicable.

Nice To Haves

• Health science background such as PharmD, RN, or MPH.
• Master’s degree or advanced health-related degree.
• Prior involvement in system implementations or PV technology optimization.

Responsibilities

• Serve as a Case Management subject matter expert, providing operational guidance, technical support, and input to leadership.
• Support appropriate staffing and daily operational coverage to meet timelines and deliverables.
• Oversee day-to-day ICSR case management operations and maintain oversight reports to monitor quality, performance, and compliance.
• Ensure compliance with internal procedures and global regulatory requirements, reporting timelines, and obligations.
• Oversee outsourced case processing performed by the PV vendor, ensuring accuracy, consistency, and adherence to established processes.
• Develop and review training materials to support team competency, process consistency, and audit and inspection readiness.
• Collaborate with Safety Data Management to provide business input and operational requirements for enhancements to the Global Intake Tool and Global Safety Database.
• Maintain and update Data Entry Conventions, ICSR job aids, and related process documents.
• Collaborate with Clinical Study Teams and Medical Safety on case-related activities for assigned products, including SAE reconciliation, protocol reviews, Safety Management Plans, and REMS activities.
• Provide data to support operational decision-making on case management and ICSR-related issues, escalating matters when appropriate.
• Support continuous improvement initiatives to enhance efficiency, quality, and regulatory compliance.
• Review Pharmacovigilance Agreements and Safety Management Plans to ensure Case Management requirements are captured and executed.
• Support regulatory authority inspections and internal or third-party audits, including serving as an interviewee and providing documentation and responses.
• Support preparation, tracking, and completion of CAPAs and process deviations, ensuring timely and effective remediation.
• Identify and proactively escalate operational issues or risks to support timely mitigation.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided basic life insurance.
• Accidental death and dismemberment insurance.
• Short-term and long-term disability insurance.
• Tuition reimbursement.
• Student loan assistance.
• Generous 401(k) match.
• Flexible time off.
• Paid holidays.
• Paid leave programs.
• Other company-provided benefits.
• Incentive opportunity.

What This Job Offers

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