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

Medical insurance

Dental coverage

Vision coverage

401(k) match

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager, Global Case Management to lead day‑to‑day ICSR management activities and ensure compliant, high-quality deliverables. The role partners across Clinical, Medical Safety, Data Management and Alliance teams to support the safety lifecycle.

The position may contribute to inspections and continuous improvement, overseeing outsourced PV activities and tool enhancements while guiding staff toward timely case processing and audit readiness.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum 3 years in Pharmacovigilance or case management.
• Experience with global PV operations.
• Experience with outsourced PV model.
• Experience supporting inspections and audits.
• Proficiency with PV databases and intake tools.

Responsibilities

• Serve as SME for Case Management, guiding operations.
• Oversee day-to-day ICSR case management and reports.
• Ensure regulatory compliance and timely reporting.
• Oversee PV vendor case processing and quality.
• Develop training materials for team readiness.
• Collaborate on enhancements to intake tools and databases.
• Maintain process documents and data conventions.
• Support cross‑functional safety activities for product lifecycle.
• Provide data for operational decision‑making and issue escalation.
• Support CAPA tracking and remediation efforts.
• Identify and escalate operational risks to mitigate.

Skills

Accountability for Results

Strategic Thinking

Patient & Customer Centricity

Impactful Communication

Respectful Collaboration

Empowered Development

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field

Tools

Safety databases

Intake tools

PV systems

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager, Global Case Management to lead day‑to‑day ICSR management activities and ensure compliant, high-quality deliverables. The role partners across Clinical, Medical Safety, Data Management and Alliance teams to support the safety lifecycle.

The position may contribute to inspections and continuous improvement, overseeing outsourced PV activities and tool enhancements while guiding staff toward timely case processing and audit readiness.