Senior Director, Global Medical Review Lead

Position Summary Serves as the key stakeholder and subject matter expert (SME) representing Medical review function in internal audits, and health authority inspections. Being available on-site for inspections, internal audit and critical business activities, including at short notice. Provides oversight of the safety profile of Otsuka products Leads the development and execution of medical review strategies for investigational and marketed products Provides strategic leadership of the Global Medical review function and collaborates with other PV functions, vendors and partners. Serves as a member of the Global Medical Safety (GMS) Leadership Team partnering closely with the GMS Head Meets routinely with product specific GPV team members and acts as principal liaison for medical review matters to engage with regulatory agencies on product safety issues. Key Job Responsibilities Represents GPV Medical Safety department from a medical review standpoint as the key stakeholder in internal, external and health authority inspections, to ensure and sustain inspection readiness. Defines and drives the global vision and strategic direction for Medical Review, ensuring alignment with evolving regulatory requirements, industry best practices, and the overarching objectives of the Global Medical Safety organization. Leads the creation, revisioning and implementation of medical review Standard Operating Procedures, Work Practices, Job Aids and other guidance documents relevant to medical review. Drives adoption of best practices and continuous improvement initiatives. Mentors and develops a high-performing team of medical reviewers, fostering a culture of accountability, innovation, and professional growth. Oversees medical review of Individual Case Safety Reports (ICSRs) as the global medical review lead to ensure quality and accuracy of ICSRs by implementing and overseeing key performance metrics. Implement corrective actions and improvement plans as needed. Chairs periodic global medical review meetings with the attendance of in-house, subsidiary, partner, and vendor medical reviewers. Provides strong leadership and oversight of vendor activities related to the Medical review function, ensuring alignment with Otsuka’s standards and regulatory expectations. Provides oversight of the safety profile of Otsuka products (both drugs and devices) through monitoring safety data, conducting risk analysis, and monitoring adverse events according to GCP and regulatory guidelines, to protect the safety of the patients and consumers and the company from legal implications. Supports on development, implementation, and maintenance of GPV signal detection process. Works in conjunction with related departments to develop and maintain a signal detection plan for use in all product life cycles. Works with Medical safety Product leaders and represents MR at Labeling Committee/ Executive Committee discussions on new information impacting product profile. Keeps abreast of industry standards and initiatives regarding signal detection, risk management, and risk communication. Manages the continuous analysis of adverse events to identify safety signals and trends for assigned products. Performs review and approval of the clinical trial medical coding. Serves as back-up product/ medical monitor to coordinate clinical study safety and spontaneous reporting of assigned Otsuka products. Maintains accurate and complete knowledge of assigned investigational and marketed products being monitored by Otsuka, co-marketers, co-sponsors, and/ or affiliates. Works closely with PV Operations, Safety Database Management, Compliance Business Management and other PV functions. Maintains a thorough understanding of internal and external interactions, and scope of work assigned to GPV Medical Safety and PV Operations departments. Meets routinely with product specific GPV team members to review product safety issues. Reviews each product (e.g., IND/NDA Periodic, CSR, Summary Analysis, etc.) and accompanying data for completeness, consistency, accuracy, and clarity. Prepares/review safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports. Discusses safety issues with personnel in therapeutic specialty groups at meetings with vendors, licensing partners, agents, contract research organizations, and clinical site investigators. Acts as the principal liaison for Medical review matters, collaborating closely with GPV Medical Safety Product Leaders, to engage with global regulatory agencies on product safety issues. Demonstrates flexibility and responsiveness by being available on-site, even at short notice, to support urgent business needs, inspections, or regulatory engagements. Knowledge, Ski8lls, Competencies, Education, and Experience Required: Knowledge Strong knowledge of global regulatory guidelines pertaining to pharmacovigilance Strong knowledge of MedDRA and any safety databases Strong medical background evidenced by clinical training. Extensive experience interacting with global regulatory authorities and representing inspections Solid knowledge of FDA and Global PV regulations Knowledge of clinical trials, good clinical practices, and ICH guidelines. Immunology, Neurology or Rare disease experience is a plus. Experience working in a global and cross-functional pharma setting. Skills Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources. Effective communication, strategic thinking and leadership skills. Strong computer skills with demonstrated experience in working with Microsoft applications (Word, Excel, PowerPoint, Outlook, SharePoint, and Teams). Knows how/when to apply organizational policy or procedures to a variety of situations. Education and Related Experience M.D. from an accredited medical school with at least 8-10+ years of Safety Surveillance experience in pharmaceutical industry Experience with both development and product launch/post marketed products. Acted as in-house authority/leader in Safety and Pharmacovigilance, and accountable for Safety of assigned products. Experience interacting with global regulatory authorities such as EMA, MHRA, PMDA, Health Canada. Prior supervisory and vendor oversight experience Physical Demands and Work Environment Being available on-site to support business needs and able to travel, including internationally (up to 25%) as required. 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 $249,973.00 - Maximum $388,125.00, 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. 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; Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. 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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.