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.