Senior Global ICSR Case Management Lead

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); On-site; USD 135,000 - 201,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Company provided life insurance

Accidental death & dismemberment

Short-term and long-term disability

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Other company provided benefits

Job summary

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Senior Manager, Global Case Management (Case Management Operations) to lead day-to-day ICSR processing, oversee vendor relationships, ensure regulatory compliance, and deliver high-quality safety deliverables.

This role partners with Clinical Safety, Data Management, and Alliance Management to support inspections, CAPAs, process improvements, and training materials; the incumbent will drive readiness and quality across global PV

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 3 years in Pharmacovigilance, case management, or related drug safety functions.
• Experience with global teams or large-scale PV operations.
• Strong knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, CIOMS).
• Experience working with outsourced PV models.
• Experience supporting inspections and audit remediation.

Responsibilities

• Serve as SME for Case Management, providing operational guidance and input to leadership.
• Oversee day-to-day ICSR case management operations and oversight reports.
• Ensure compliance with internal procedures and global regulatory requirements.
• Provide oversight of outsourced PV processing and ensure accuracy and consistency.
• Develop and review training materials to ensure team competency and inspection readiness.
• Collaborate with Safety Data Management to support tool enhancements and data quality.

Skills

Case Management

Regulatory Knowledge

PV Systems

Vendor Oversight

Cross-functional Collaboration

Training & Documentation

Education

Bachelor's degree in Life Sciences

Tools

Safety databases

Intake tools

Job description

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Senior Manager, Global Case Management (Case Management Operations) to lead day-to-day ICSR processing, oversee vendor relationships, ensure regulatory compliance, and deliver high-quality safety deliverables.

This role partners with Clinical Safety, Data Management, and Alliance Management to support inspections, CAPAs, process improvements, and training materials; the incumbent will drive readiness and quality across global PV