Otsuka Pharmaceutical Co. is hiring: Director, Global Case Management in Princet

The Director, Global Case Management, is responsible for providing strategic oversight, operational leadership, and functional expertise for global Individual Case Safety Report (ICSR) management activities. This role ensures the highest standards of compliance, quality, and operational efficiency across case processing activities, including both internally managed workflows and those performed by external vendors. The role partners closely with cross functional teams—including Clinical, Medical Safety, Data Management, and Alliance Management—to support the full safety lifecycle of assigned products. The Director also serves as the backup to the Global Head of Case Management and plays a key role in regulatory inspections, audits, and continuous improvement initiatives.

This role has direct reports including FTEs and CWs/MSPs, who may be onsite or remote.

KEY RESPONSIBILITIES

• Serve as the designated SME to the Case Management team, supporting leadership oversight and decision-making ‑as needed.
• Manage resource planning and ensure appropriate operational coverage for Case Management team responsibilities.
• Oversee all ICSR case management operations and procedures, including development and maintenance of oversight reports to ensure high-quality ‑quality execution.
• Ensure adherence to company procedures and global regulatory requirements to maintain full compliance with reporting timelines and obligations.
• Provide leadership and oversight of case processing activities outsourced to the PV vendor, ensuring consistency, accuracy, and compliance.
• Develop, review, and approve training materials to support team competency, operational consistency, and inspection readiness.
• Collaborate with the Safety Data Management team to define business requirements and support enhancements for the Global Intake Tool and Global Safety Database.
• Maintain and continuously improve Data Entry Conventions, ICSR Job Aids, and related procedural and guidance documents.
• Partner with Clinical Study Teams and Medical Safety Teams on case processing–related activities for assigned products, including support for clinical safety (e.g., SAE reconciliation, protocol review, Safety Management Plans) and post‑marketing programs (e.g., REMS).
• Serve as decision maker for case management and ICSR related‑related operational issues.
• Lead continuous improvement initiatives at the team, functional, or global level to optimize quality, efficiency, and compliance.
• Review Pharmacovigilance Agreements (PVAs) and Safety Management Plans to ensure case management requirements are accurately reflected.
• Participate in global Regulatory Authority inspections and internal/third party audits, including serving as an interviewee and providing timely‑party audits, including serving as an interviewee and providing timely responses and documentation.
• Prepare, track, and respond to CAPAs and process deviations, ensuring timely and effective remediation.
• Proactively identify and escalate issues or risks.

JOB SCOPE (key facts & figures)

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
• Extensive experience (typically 6-8+ years) in Pharmacovigilance, case management, or related drug safety functions.
• Demonstrated leadership experience managing 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 overseeing case processing vendors and managing outsourced PV activities.
• Proven success in inspection 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 post‑marketing 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.