About this role
The Senior Manager, Global Case Management (Case Management Operations) , provides day‑to‑day operational support, subject matter expertise, and oversight of global Individual Case Safety Report (ICSR) management activities. This role supports the effective execution of case processing workflows—both internally managed and vendor‑executed—ensuring accuracy, compliance, and high‑quality deliverables. The Senior Manager works closely with cross‑functional partners such as Clinical, Medical Safety, Data Management, and Alliance Management to support the safety lifecycle and ensure timely case management deliverables.
The Senior Manager may contribute to regulatory inspections, audits, and continuous improvement efforts by supporting process implementation, addressing operational challenges, and helping maintain inspection readiness. KEY RESPONSIBILITIES Serve as a subject matter expert (SME) for the Case Management team, providing operational guidance, technical support, and input to leadership as needed. Support appropriate staffing and daily operational coverage to meet Case Management timelines and deliverables.
Oversee day‑to‑day ICSR case management operations, including maintaining oversight reports to monitor quality, performance, and compliance. Ensure compliance with internal procedures and global regulatory requirements to meet reporting timelines and obligations. Provide operational oversight of outsourced case processing activities performed by the PV vendor, ensuring accuracy, consistency, and adherence to established processes.
Develop and review training materials to ensure team competency, process consistency, and audit/inspection readiness. Collaborate with the Safety Data Management team to provide business input and operational requirements for enhancements to the Global Intake Tool and Global Safety Database. Maintain and update Data Entry Conventions, ICSR job aids, and related process documents to support operational consistency and quality.
Collaborate with Clinical Study Teams and Medical Safety on case‑related activities for assigned products, supporting clinical and postmarketing safety deliverables (e.g., SAE reconciliation, protocol reviews, Safety Management Plans, REMS activities). Provide necessary data to support operational decision‑making for case management and ICSR‑related issues, escalating matters appropriately when needed. Support continuous improvement initiatives within the team or function to enhance efficiency, quality, and regulatory compliance.
Review Pharmacovigilance Agreements (PVAs) and Safety Management Plans to ensure Case Management requirements are clearly captured and executed. Support Regulatory Authority inspections and internal/third‑party audits, including serving as an interviewee and providing timely documentation and responses. Support the preparation, tracking, and completion of CAPAs and process deviations, ensuring effective and timely remediation.
Identify and proactively escalate operational issues or risks to ensure timely mitigation. JOB SCOPE (key facts & figures) Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field. Experience (minimum 3 years) in Pharmacovigilance, case management, or related drug safety functions.
Experience working with global teams or large scale PV operations. Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, CIOMS, and other regional health authority requirements. Experience working with an outsourced PV model.
Experience supporting inspections and audit participation, including presenting, responding, and leading remediation efforts. Proficiency with safety databases, intake tools, and related PV systems. QUALIFICATIONS/ EXPERIENCE REQUIRED Health Science background (e.g., PharmD, RN, MPH), Master’s degree or advanced health related degree a plus.
Experience supporting clinical trial safety and postmarketing PV activities. Prior involvement in system implementations or PV technology optimization. Experience in a global matrixed organization COMPETENCIES REQUIRED 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.
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. Minimum $134,615.00 - Maximum $201,250.00, 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. Application Deadline : This will be posted for a minimum of 5 business days.
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. Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 . Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community.
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