Global PV Case Management Lead (Remote)

Otsuka Pharmaceutical; United States; Remote; USD 121,000 - 181,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) match

Tuition reimbursement

Paid holidays and leave

Job summary

Otsuka Pharmaceutical is seeking a Manager Global Case Management Submissions to lead regulatory reporting for adverse event data across global markets. Location: USA Remote, full-time role within Drug Safety and Pharmacovigilance, focused on safety submissions and compliance with timelines.

The role emphasizes maintaining compliant safety documents, monitoring submission workflows in the global safety database, coordinating with safety surveillance teams, and driving process improvements.

Qualifications

• Global safety reporting regulations knowledge (FDA/ICH/EU)
• Experience with safety case processing and reporting metrics
• Familiarity with case management and regulatory submissions
• Vendor/ CRO management experience is a plus

Responsibilities

• Oversees internal submissions for all destinations, regulatory bodies, partners and internal teams
• Tracks ICSR timelines to ensure regulatory submissions meet requirements
• Identifies roadblocks and proposes solutions for major regulatory submissions
• Ensures accuracy of electronic and hard copy submissions
• Supports regulatory interactions and process improvements across PV operations
• Manages safety report scheduling and timelines, and tracks compliance with timelines
• Participates in cross-functional meetings as submissions lead
• Assists with special projects and back-up to PV Operations teams

Skills

Scientific data interpretation

Communication skills

MS Office

Project management

Attention to detail

Education

Bachelor's degree in life sciences

Tools

ARGUS Safety Database

Regulatory databases

Job description

Otsuka Pharmaceutical is seeking a Manager Global Case Management Submissions to lead regulatory reporting for adverse event data across global markets. Location: USA Remote, full-time role within Drug Safety and Pharmacovigilance, focused on safety submissions and compliance with timelines.

The role emphasizes maintaining compliant safety documents, monitoring submission workflows in the global safety database, coordinating with safety surveillance teams, and driving process improvements.