Global ICSR & PV Case Management Lead

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); On-site; USD 135,000 - 201,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, Global Case Management to oversee ICSR processing and ensure regulatory compliant, high-quality case deliverables across global teams.

You will partner with Clinical, Medical Safety, Data Management, and Alliance Management to support the safety lifecycle, inspections, and continuous process improvements. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• 3+ years of pharmacovigilance or case management experience.
• Experience with global PV operations and inspections is preferred.

Responsibilities

• Serve as SME for Case Management and provide operational guidance to leadership.
• Oversee day-to-day ICSR case management operations and oversight reports.
• Ensure compliance with global regulatory requirements and internal procedures.
• Manage outsourced PV activities and ensure training materials are up to date.
• Collaborate with Clinical and Medical Safety teams on safety deliverables.

Skills

Accountability for Results

Strategic Thinking

Problem Solving

Patient Centricity

Communication

Collaboration

Empowered Development

Education

Bachelor's degree in Life Sciences / Pharmacy / Nursing

Tools

Safety databases

Intake tools

PV systems

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, Global Case Management to oversee ICSR processing and ensure regulatory compliant, high-quality case deliverables across global teams.

You will partner with Clinical, Medical Safety, Data Management, and Alliance Management to support the safety lifecycle, inspections, and continuous process improvements. Travel up to 10% may be required.