Global PV Submissions Manager — Case Management

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

Job summary

Otsuka is seeking a Manager, PV Case Management (Submissions) to lead the internal submissions process for worldwide regulatory reporting. You will track ICSR timelines, ensure compliant submissions, and support interactions with regulatory agencies while driving process improvements.

The role requires deep knowledge of global safety reporting regulations and experience with case processing, vendor management, and cross‑functional collaboration within a GMP environment.

Qualifications

• Minimum of 5 years drug safety experience.
• Degree preferred to be in Bachelor of Science or related healthcare degree but may be waived for relevant experience.
• Global Drug Safety Case processing experience.
• Knowledge of global safety reporting regulations.

Responsibilities

• Oversees the internal submissions process for all destinations including regulatory bodies, partners and internal departments.
• Tracks and monitors all ICSR timelines to ensure compliant submissions to agencies and CROs.
• Identifies roadblocks and helps schedule major regulatory submissions.
• Ensures accuracy and completeness of electronic and hard copy submissions.
• Supports interactions with regulatory agencies reviewing submissions content.
• Participates in cross‑functional meetings as the submissions lead.
• Maintains safety report scheduling and timelines; analyzes bottlenecks.

Skills

Communication

Writing

Project management

Microsoft Office

Attention to detail

Regulatory knowledge

Education

Bachelor of Science or related healthcare degree

Tools

ARGUS Safety Database

Job description

Otsuka is seeking a Manager, PV Case Management (Submissions) to lead the internal submissions process for worldwide regulatory reporting. You will track ICSR timelines, ensure compliant submissions, and support interactions with regulatory agencies while driving process improvements.

The role requires deep knowledge of global safety reporting regulations and experience with case processing, vendor management, and cross‑functional collaboration within a GMP environment.