Senior Global PV Submissions Lead

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

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Paid time off and holidays

Job summary

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Manager, PV Case Management (Submissions) to lead regulatory submissions for adverse event reports in line with FDA, ICH, and EU guidelines. The role ensures timely submissions and maintains core safety documents while monitoring schedules and workflow in the GPV system.

You will coordinate with PV operations and cross-functional teams, manage timelines, and support health authority interactions while driving process improvements and

Qualifications

• Degree preferred in science or healthcare; may be waived for relevant experience.
• Minimum of 5 years drug safety experience.
• Experience with safety database functionality and regulatory submissions.

Responsibilities

• Oversee internal submissions for all destinations including regulatory bodies, partners and internal departments.
• Track ICSR timelines to ensure compliant submissions to agencies and CROs.
• Identify roadblocks and support scheduling and timelines of major regulatory submissions.
• Ensure accuracy and completeness of electronic and hard copy submissions.
• Support interactions with regulatory agencies reviewing submission content.
• Contribute to process improvement across the organization.
• Assist with other regulatory activities and special projects as required.
• Escalate and investigate safety/non-compliance issues with PV Operations team.

Skills

Regulatory submissions

Global regulations

ARGUS Safety

Project management

Vendor management

Communication

Writing skills

Education

Bachelor of Science or related healthcare degree

Pharmacovigilance training

Tools

ARGUS Safety

Job description

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Manager, PV Case Management (Submissions) to lead regulatory submissions for adverse event reports in line with FDA, ICH, and EU guidelines. The role ensures timely submissions and maintains core safety documents while monitoring schedules and workflow in the GPV system.

You will coordinate with PV operations and cross-functional teams, manage timelines, and support health authority interactions while driving process improvements and