Manager, Global Case Management

Otsuka Pharmaceutical Companies (U.S.)

. Oversee the internal submissions process for regulatory bodies, partners, and internal departments .

Posted 10/30/2026full-timeRemote • United StatesMid-LevelSenior💰 $121,103 - $181,125 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of global safety reporting regulations and pharmacovigilance requirements, with a strong focus on compliance and process improvement. Proficient in managing safety report submissions and case processing within a matrix environment, ensuring accuracy and timely delivery.

Highest-signal resume keywords

Global Drug Safety ExperienceKnowledge Of ARGUS Safety DatabaseRegulatory Submission ComplianceProject Management SkillsStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case ManagementSafety Report Submission MetricsSafety Database FunctionalityPharmacovigilance RequirementsRegulatory GuidelinesData AnalysisSubmission TrackingRoot Cause AnalysisProcess ImprovementAdverse Event Reporting

Soft Skills

Attention To DetailProblem-Solving AbilityAbility To Work Under PressureOrganizational SkillsCollaboration Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

FDA RegulationsICH GuidelinesEU RegulationsDrug SafetyPharmacovigilanceSafety SurveillanceCompliance MonitoringCross-Functional CollaborationStandard Operating ProceduresE2B Warnings

About the role

Key responsibilities & impact

Oversee the internal submissions process for regulatory bodies, partners, and internal departments
Track and monitor ICSR timelines to ensure compliant submissions to regulatory agencies, business partners, and CROs
Identify roadblocks and solutions supporting regulatory submission schedules and timelines
Ensure accuracy and completeness of electronic and hard-copy regulatory submissions
Support interactions with regulatory agencies reviewing submission content
Contribute to organization-wide process improvement initiatives
Support PV Operations and investigate safety and non-compliance issues
Identify root causes for late ICSR submissions and implement corrective actions
Manage safety report scheduling and timelines
Track compliance with regulatory timelines and submission requirements
Collaborate with safety surveillance and case processing teams to achieve submission timelines
Assess new regulations’ impact on safety database reporting rules and oversee updates
Participate in cross-functional meetings as submissions lead
Organize and track safety information requests and responses
Generate and use reports to monitor daily case workload, reports due, worklists, bottlenecks, and resource gaps
Participate in setup and maintenance of adverse event workflow processes, policies, and standard operating procedures
Ensure compliance with corporate and departmental standard operating procedures
Contribute to standardized practices, procedures, metrics, and productivity/performance measures
Assist with ICSR health authority responses
Provide support and backup to the Global PV Workflow Associate
Perform other activities as directed by Drug Safety and Pharmacovigilance management
Provide management and oversight of E2B warnings and failures

Requirements

What you’ll need

Sufficient experience and thorough knowledge of global safety reporting regulations and guidelines, including FDA, ICH, and EU regulations and pharmacovigilance requirements
Knowledge of the ARGUS Safety Database
Experience with case management and safety report submission metrics
Knowledge and prior experience in case processing
Excellent technical skills and ability to comprehend and integrate scientific data from varied sources
Strong communication and writing skills
Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook
Ability to apply organizational policy or regulatory procedures to varied situations
Ability to work under pressure and meet tight timelines
Ability to work effectively in a matrix environment
Strong attention to detail and problem-solving ability
Excellent project management skills and ability to align internal and external resources
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
Bachelor of Science or related healthcare degree preferred; may be waived for relevant experience
Minimum of 5 years of drug safety experience required
Demonstrated proficiency in safety database functionality
Global Drug Safety case processing experience
Safety experience involving AE/SAE reports, narratives, queries, safety databases, and regulatory submissions
Approximately 10% travel

Benefits

Comp & perks

Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company-provided benefits
Incentive opportunity