Manager, Global Case Management

🔥 16 minutes ago

🇺🇸 United States – Remote

💵 $121.1k - $181.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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

• 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

• 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

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