Senior Director, Medical Review Expertise

Position Summary Serve 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, playing a pivotal role in patient safety. Lead the strategic 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 teams, vendors, and partners. Join the Global Medical Safety (GMS) Leadership Team and collaborate closely with the GMS Head for impactful decision-making. 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 Represent the GPV Medical Safety department during inspections, promoting ongoing inspection readiness. Define and drive the global vision and strategic direction for Medical Review, aligning with evolving regulatory requirements. Lead the creation, revision, and implementation of Standard Operating Procedures, Work Practices, and other documents related to Medical Review. Mentor and develop a high-performing team of medical reviewers, fostering a culture of accountability and growth. Oversee the medical review of Individual Case Safety Reports (ICSRs), ensuring their quality and accuracy through performance metrics. 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. Monitor safety data, conduct risk analyses, and track adverse events to uphold Otsuka's product safety profile. Assist in developing and maintaining the GPV signal detection process in collaboration with relevant departments. Work closely with Medical Safety Product leaders, representing Medical Review in product profile discussions. Stay updated on industry standards in 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 and its affiliates. Collaborate with PV Operations, Safety Database Management, Compliance Business Management, and other PV functions. 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 and clarity. Prepare and review safety summaries for inclusion in medical information documents. Engage with therapeutic specialty group personnel about safety issues during vendor and partner meetings. Act as the key liaison for medical review topics, collaborating with GPV Medical Safety Product Leaders. Demonstrate flexibility and readiness to address urgent business needs, inspections, or regulatory interactions on-site. Knowledge, Skills, and Experience Required: Extensive understanding of global regulatory guidelines related to pharmacovigilance. Proficient in MedDRA and familiar with safety databases. Strong medical background supported by clinical training. Experience interacting with global regulatory authorities 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, cross-functional pharmaceutical environment. Skills Excellent technical capabilities for integrating 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, 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, accountable 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 willing to travel internationally (up to 25%) as necessary. Competencies Accountability for Results: Maintain focus on critical strategic objectives while leading change. Strategic Thinking & Problem Solving: Make decisions considering long-term customer and business impacts. Patient & Customer Centricity: Keep continuous focus on the needs of customers and key stakeholders. Impactful Communication: Communicate clearly while influencing 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. 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, life and disability insurance, tuition assistance, student loan support, generous 401(k) match, flexible time off, paid holidays, and more. Disclaimer: This job description reflects the general nature of the work performed and is not exhaustive. Otsuka reserves the right to modify responsibilities as necessary. Otsuka is an equal opportunity employer and encourages applications from all qualified individuals. 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 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.

Created: 2026-03-11