Global PV Submissions Lead - Regulatory Reporting

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager of PV Case Management (Submissions) to lead the internal submissions process for adverse event reports across global destinations. You will ensure compliant submissions, coordinate with regulatory bodies, CROs, and partners, and drive process improvements within the GPV organization.

You will manage safety report scheduling, maintain submission timelines, and collaborate with PV operations to resolve issues, while staying current on

Qualifications

• Must have thorough knowledge of global safety reporting regulations (FDA, ICH, EU)
• Experience with case management and safety submissions metrics
• Knowledge of safety databases and global PV processes
• Experience managing vendors, partners, and CROs preferred

Responsibilities

• Oversees internal submissions for destinations including regulatory bodies and partners
• Tracks ICSR timelines to ensure compliant submissions
• Identifies roadblocks and supports scheduling and timelines
• Ensures accuracy of electronic and hard copy submissions
• Supports interactions with regulatory agencies reviewing content
• Contributes to process improvement across the organization
• Assists with other regulatory activities and special projects
• Manage safety report scheduling and timelines with PV Operations team
• Monitor regulatory timelines and submission requirements
• Collaborate with safety surveillance and case processing teams to meet timelines
• Assess impact of new regulations on reporting rules in the safety database
• Participate in cross-functional meetings as submissions lead
• Organize and track safety information requests and responses
• Maintain GPVP & GCP knowledge and standard operating procedures

Skills

Regulatory compliance

ICSR submissions

Project management

Data analysis

Communication

Education

Bachelor's degree in Life Sciences

Tools

ARGUS Safety Database

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Manager of PV Case Management (Submissions) to lead the internal submissions process for adverse event reports across global destinations. You will ensure compliant submissions, coordinate with regulatory bodies, CROs, and partners, and drive process improvements within the GPV organization.

You will manage safety report scheduling, maintain submission timelines, and collaborate with PV operations to resolve issues, while staying current on