Manager Global Case Management Submissions

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

Position Summary

As a member of the Drug Safety and Pharmacovigilance department, the Manager, PV Case Management (Submissions) is responsible for participating in the reporting of adverse event data in compliance with applicable global regulations. The Manager, PV Case Management (Submissions) will ensure responsibility for all the reports and submissions for the company’s medicinal and device products covering pre and post marketing activities. The role holder will be a dedicated employee who will be supporting the reporting system of the GPV department which includes managing the safety report schedule and reporting rules. With the responsibility for maintaining compliant and core safety documents, planning all updates scheduling and carrying out all submissions within applicable regulatory timelines. The Manager, PV Case Management (Submissions) will participate in the set-up and development of monitoring tools and maintenance of submissions workflow within the global safety database to meet global regulatory reporting requirements. In addition Manager, PV Case Management (Submissions) will assist with the reconciliation of submission dates, site audit requests, and health authority responses. The Manager, PV Case Management (Submissions) will assist in special projects as assigned. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting. Must also maintain a thorough knowledge and understanding of internal and business partner reporting rules.

Key Job Responsibilities

• Oversees the internal submissions process for all destinations including regulatory bodies, partners and internal departments.
• Tracks and monitors all ICSR timelines to ensure that submissions to regulatory agencies, business partners, and contract research organizations (CROs) are compliant with the regulatory requirements.
• Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions.
• Ensures the accuracy and completeness of electronic and hard copy regulatory submissions.
• Provides support during interactions with regulatory agencies reviewing submission content.
• Contributes to process improvement initiatives across the organization.
• Assists with other regulatory activities and special projects as required.
• Supports the Manager PV Operations (Global ICSR Quality and Analytics) and team, escalating and investigating safety and non‑compliance issues.
• In conjunction with the Manager PV Operations (Global ICSR Quality and Analytics) identify root causes for late ICSR submissions and implementation of appropriate corrective actions.
• Actively manages the safety report scheduling and timelines.
• Tracks and maintains compliance with regulatory timelines and submission requirements.
• Works closely with the safety surveillance and case processing teams to achieve submission timelines.
• Assesses impact of new regulations on the safety database reporting rules and oversees updates as appropriate.
• Participates in cross‑functional meetings as the submissions lead.
• Is responsible for organizing and tracking safety information requests and responses.
• Maintains a strong GPVP & GCP knowledge.
• Generates and uses established reports to monitor daily case workload and reports due, working with team members to identify potential bottlenecks or resource gaps and coordinate work plans accordingly.
• Generates and uses established reports to monitor reports worklist and additional worklist as needed.
• Participates in the set‑up and maintenance of adverse event workflow processes, department policies, and standard operating procedures.
• Follows company processes and guidelines for case management and closure activities, and adheres to company templates and guidelines for documentation and communications.
• Ensures compliance with corporate and departmental standard operating procedures.
• Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.
• Assists in the preparation of ICSR health authority responses.
• May provide support and back‑up to the Global PV workflow associate.
• Performs other activities as directed by Drug Safety and Pharmacovigilance management.
• Provides management and oversight of E2B warnings and failures.

Knowledge

• Must have sufficient experience and a demonstrated thorough knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance.
• Knowledge of the ARGUS Safety Database.
• Experience of case management and safety report submissions metrics.
• Knowledge and prior experience in case processing*.
• Knowledge of the interworking’s of Global Pharmacovigilance organization is desired.
• Experience with managing vendors, partners, and/or CRO's preferred.

Skills

• Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
• Strong communication and writing skills.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Knows how/when to apply organizational policy or regulatory procedures to a variety of situations.
• Ability to work under pressure in order to meet tight timelines.
• Able to work effectively in a matrix environment.
• Strong attention to detail along with the ability to problem solve.
• The ability to provide direction to a team, and to influence peers and team members appropriately.
• Excellent project management skills with the ability to align internal and external resources.
• Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations.

Education and Related Experience

• Degree preferred to be in Bachelor of Science or related healthcare degree however may be waived for relevant experience**.
• Minimum of 5 years drug safety experience required.
• Demonstrated proficiency in safety database functionality.
• Global Drug Safety Case processing experience__Safety experience is defined as actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance.

Physical Demands and Work Environment

• Travel (approximately 10%).

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long‑term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect.
• Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Salary

Minimum $121,103.00 - Maximum $181,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Benefits

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Equal Opportunity & Diversity

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka - people creating new products for better health worldwide. In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond- under any circumstances, for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.