Senior Director, Global Medical Review Expert

Position Summary Act as the primary stakeholder and subject matter expert (SME) for the Medical Review function during internal audits and health authority inspections. Be prepared to be on-site for inspections, audits, and critical business activities, often at short notice. Oversee and ensure the safety profile of Otsuka products. Lead the strategy development and execution for medical reviews concerning investigational and marketed products. Provide strategic oversight of the Global Medical Review function while collaborating with other pharmacovigilance functions, vendors, and partners. Join the Global Medical Safety (GMS) Leadership Team and collaborate closely with the GMS Head. Engage with product-specific Global Pharmacovigilance (GPV) team members as the main liaison for medical review issues while interfacing with regulatory agencies about product safety matters. Key Responsibilities Serve as the key representative for the GPV Medical Safety department during inspections to ensure ongoing inspection readiness. Define and drive the global vision and strategic direction for Medical Review, ensuring alignment with evolving regulatory requirements and industry best practices. Lead the creation, revision, and implementation of Standard Operating Procedures, Work Practices, Job Aids, and other documents related to Medical Review, promoting best practices and continuous improvement. Mentor and develop a high-performing team of medical reviewers, fostering a culture of accountability and professional growth. Oversee the medical review of Individual Case Safety Reports (ICSRs), ensuring their quality and accuracy by implementing key performance metrics and managing corrective actions as necessary. Chair regular global medical review meetings, including participation from in-house, subsidiary, partner, and vendor medical reviewers. Provide leadership and oversight of vendor activities related to the Medical Review function, ensuring compliance with Otsuka's standards and regulatory expectations. Monitor safety data, conduct risk analyses, and keep track of adverse events to uphold the safety profile of Otsuka's products, thereby protecting patient safety and minimizing legal implications for the company. Assist in the development and maintenance of the GPV signal detection process. Collaborate with related departments to create a signal detection plan applicable throughout all product life cycles. Work with Medical Safety Product leaders, representing Medical Review in discussions that impact product profiles. Stay updated on industry standards regarding signal detection, risk management, and communications. Continuously analyze adverse events to identify safety signals and trends for assigned products. Review and approve clinical trial medical coding as part of the oversight process. Act as a backup product/medical monitor, coordinating clinical study safety and spontaneous reporting of assigned Otsuka products. Maintain thorough knowledge of investigational and marketed products monitored by Otsuka, co-marketers, co-sponsors, and/or affiliates. Work closely with PV Operations, Safety Database Management, Compliance Business Management, and other PV functions. Maintain a solid understanding of internal and external interactions relating to GPV Medical Safety and PV Operations departments. Meet regularly with product-specific GPV team members to discuss product safety issues. Review product documents (e.g., IND/NDA Periodics, CSRs, Summary Analysis) for completeness, consistency, accuracy, and clarity. Prepare and review safety summaries for inclusion in medical information documents, including analyzing similar events in alert reports. Engage with therapeutic specialty group personnel about safety issues in meetings with vendors and partners. Act as the key liaison for medical review topics, collaborating with GPV Medical Safety Product Leaders to engage with global regulatory agencies on safety issues. Demonstrate flexibility and readiness to be available on-site to address urgent business needs, inspections, or regulatory interactions. Knowledge, Skills, and Experience Required: In-depth understanding of global regulatory guidelines related to pharmacovigilance. Proficient in MedDRA and familiarity with safety databases. Strong medical background, supported by clinical training. Extensive experience interacting with global regulatory authorities and representing during inspections. Solid knowledge of FDA and global PV regulations. Familiarity with clinical trials, good clinical practices, and ICH guidelines. Experience in immunology, neurology, or rare diseases is advantageous. Proven record in a global and cross-functional pharmaceutical environment. Skills Excellent technical capabilities, allowing for the integration of scientific data from diverse sources. Strong communication, strategic thinking, and leadership abilities. Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, SharePoint, and Teams). Ability to apply organizational policies and procedures effectively across varied situations. Education and Experience M.D. from an accredited medical school, along with 8-10+ years of Safety Surveillance experience in the pharmaceutical industry. Experience in both product development and post-market launch phases. Proven leadership in Safety and Pharmacovigilance, holding accountability for the safety of assigned products. Experience liaising with international regulatory authorities such as EMA, MHRA, PMDA, and Health Canada. Prior supervisory experience with vendor oversight is preferred. Work Environment Must be available on-site to meet business needs and be willing to travel internationally (up to 25%) as necessary. Competencies Accountability for Results: Maintain focus on critical strategic objectives and embody high standards of performance while leading change. Strategic Thinking & Problem Solving: Make decisions considering the long-term impacts on customers and the business. Patient & Customer Centricity: Keep a continuous focus on the needs of customers and key stakeholders. Impactful Communication: Communicate clearly and respectfully while influencing at all levels for optimal outcomes. Respectful Collaboration: Value diverse perspectives and seek partnerships that further common goals. Empowered Development: Engage in your professional development as a business essential. Salary Range: Minimum $249,973.00 - Maximum $388,125.00, with potential for incentives. Please note this range reflects typical pay for this role in the United States. Actual salary may vary based on experience, skills, and existing internal benchmarks. Application Deadline: Posted for a minimum of 5 business days. Company Benefits: Comprehensive medical, dental, vision, and prescription coverage, company-provided life and disability insurance, tuition assistance, student loan support, generous 401(k) match, flexible time off, paid holidays, and other benefits. Disclaimer: This job description reflects the general nature of the work performed and is not meant to be exhaustive. Otsuka reserves the right to modify responsibilities as necessary to meet the company's needs. Otsuka is an equal opportunity employer and encourages applications from all qualified individuals without regard to race, color, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. Individuals with disabilities or disabled veterans may request reasonable accommodations to apply for this job opening by contacting Otsuka. Job Recruiting Fraud Notice: Otsuka takes your personal information security seriously. Be aware that individuals may impersonate Otsuka employees to gain your personal information or solicit money through false job offers. Otsuka will never ask for financial information or payment of any sort during the job application process. Inspect the sender's email address to ensure it originates from an official Otsuka domain. Report any fraudulent job offers or requests for personal information accordingly. Otsuka America Pharmaceutical Inc. and its affiliates do not accept unsolicited assistance from recruitment agencies. Resumes submitted without a valid written agreement will be considered Otsuka's sole property. No fees will be paid for candidates referred by agencies without an existing agreement.

Created: 2026-03-10