Senior Director, Global Medical Review Executive

Position Summary Act as the primary stakeholder and subject matter expert for the Medical review function, actively participating in internal audits and health authority inspections. Be available on-site for inspections, internal audits, and critical business activities, adapting quickly to urgent business needs. Oversee the safety profile of Otsuka products with a commitment to maintaining high standards of patient safety. Lead the creation and execution of comprehensive medical review strategies for both investigational and marketed products. Provide visionary leadership for the Global Medical review function, collaborating with other pharmacovigilance functions, vendors, and partners. Join the Global Medical Safety (GMS) Leadership Team, working closely with the GMS Head to ensure alignment on safety matters. Engage regularly with product-specific global pharmacovigilance team members, serving as the main liaison for medical review topics and regulatory agency engagement. Key Job Responsibilities Represent the GPV Medical Safety department during inspections, ensuring and maintaining inspection readiness at all times. Define and drive the global vision and strategic direction for Medical Review, ensuring alignment with regulatory requirements and industry best practices. Lead the development, revision, and implementation of medical review Standard Operating Procedures, Work Practices, and Guidance Documents to foster continuous improvement. Mentor and cultivate a high-performing team of medical reviewers, encouraging accountability, innovation, and professional growth. Oversight of the medical review of Individual Case Safety Reports (ICSRs) to ensure their quality and accuracy through established key performance metrics. Chair periodic global medical review meetings with participation from in-house, subsidiary, partner, and vendor medical reviewers. Provide strong leadership and oversight of vendor activities related to Medical review, ensuring compliance with Otsuka's high standards and regulatory expectations. Ensure continuous oversight of the safety profile of Otsuka products by monitoring safety data and conducting risk analyses. Support the development and maintenance of the GPV signal detection process, collaborating with relevant departments for a comprehensive product lifecycle plan. Collaborate with Medical Safety Product leaders, representing Medical Review in critical discussions on new information affecting product profiles. Stay updated on industry standards regarding signal detection, risk management, and effective risk communication strategies. Conduct thorough analyses of adverse events to identify safety signals and trends relevant to assigned products. Review and approve clinical trial medical coding to maintain high standards in data integrity. Serve as a backup product/medical monitor for coordinating clinical study safety and reporting for assigned Otsuka products. Maintain comprehensive knowledge of assigned investigational and marketed products monitored by Otsuka and its partners. Work closely with PV Operations and other relevant functions to enhance data management and reporting processes. Review each product report for accuracy, consistency, and completeness in all medical information documentation. Discuss safety issues with therapeutic specialty groups and external partners during collaboration meetings. Act as the main liaison for Medical review matters, fostering collaboration with GPV Medical Safety Product Leaders to engage with global regulatory agencies. Demonstrate flexibility and a proactive approach by maintaining availability on-site for urgent business needs. Knowledge, Skills, Competencies, Education, and Experience Required: In-depth knowledge of global regulatory guidelines regarding pharmacovigilance. Proficient understanding of MedDRA and safety databases. Extensive medical background supported by clinical training. Significant experience in regulatory interactions and inspections. Solid knowledge of FDA and global pharmacovigilance regulations. Familiarity with clinical trials, good clinical practice, and ICH guidelines. Background in Immunology, Neurology, or Rare Diseases is a plus. Experience in a global, cross-functional pharmaceutical environment. Skills Strong technical skills with the ability to synthesize scientific data from diverse sources. Excellent communication, strategic thinking, and leadership capabilities. Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, Outlook, SharePoint, and Teams. Ability to apply organizational policies effectively to varied situations. Education and Experience MD from an accredited medical school with 8-10+ years in Safety Surveillance within the pharmaceutical industry. Experience with both drug development and post-marketing activities. Demonstrated leadership in Safety and Pharmacovigilance, ensuring product safety accountability. Experience interacting with global regulatory authorities. Prior supervisory experience with vendor oversight. Physical Demands and Work Environment Must be available on-site and willing to travel, including internationally (up to 25%). Competencies Accountability for Results: Maintain focus on strategic objectives and uphold high standards of performance. Strategic Thinking & Problem Solving: Make impactful decisions that consider long-term consequences for stakeholders. Patient & Customer Centricity: Consistently prioritize the needs of customers and stakeholders. Impactful Communication: Convey messages with clarity and respect, influencing stakeholders effectively. Respectful Collaboration: Encourage and value diverse perspectives to achieve shared goals. Empowered Development: Actively participate in professional development as a vital business priority. Minimum salary of $249,973.00 up to a maximum of $388,125.00, plus incentive opportunities. The salary range offered is competitive and may vary based on experience and qualifications. The company offers a comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, tuition reimbursement, 401(k) matching, flexible vacation policies, and additional benefits. Application Deadline: This position will be opened for applications for a minimum of 5 business days. Company Commitment: Otsuka is dedicated to providing equal employment opportunities and encourages applications from diverse candidates. All qualified individuals are welcome to apply regardless of race, gender, age, or any other legally protected characteristic. Fraud Awareness: Be cautious of individuals claiming to represent Otsuka and offering fictitious job opportunities. Otsuka will never request financial information or payment to apply. Ensure communication about job opportunities occurs through official channels.

Created: 2026-03-10