The Associate Director, Global Medical Review provides input into the medical review of safety data for investigational and marketed products. The role is responsible for ensuring high-quality medical review activities, consistency across internal and external reviewers, and compliance with global pharmacovigilance regulations and company procedures.
The Associate Director serves as an expert contributor and subject matter expert resource within Global Pharmacovigilance, partnering with Medical Safety Product Leaders, PV Operations, Regulatory Affairs, Clinical Development, Quality, affiliates, and vendors to support patient safety.
Demonstrate flexibility and responsiveness by being available on-site, when required, to support critical business activities, cross-functional engagements, audits, inspections, and regulatory interactions.
KEY RESPONSIBILITIES- Represents the Medical Review as subject matter expert during internal audits, partner audits, and health authority inspections as a subject matter expert, supporting inspection readiness activities and the resolution of inspection findings. This includes preparation of documentation, drafting responses to audit and inspection observations, implementation of CAPAs, and monitoring effective actions related to Medical Review activities.
- Supports the implementation of the Medical Review strategy and objectives, ensuring alignment with regulatory requirements, industry best practices, and Global Medical Safety priorities.
- Leads or contributors to the development, revision, implementation, and maintenance of Medical Review Standard Operating Procedures (SOPs), Work Practices, Job Aids, and related guidance documents. Identifies and implements process improvements to enhance quality and efficiency.
- Provides guidance, training, and feedback to vendor medical reviewers, fostering a culture of accountability, innovation, and professional growth.
- Oversees day-to-day medical review activities for Individual Case Safety Reports (ICSRs), ensuring consistency, quality, compliance, and adherence to established performance metrics. Identifies trends and supports corrective and preventive actions where necessary.
- Facilitates periodic global Medical Review meetings with internal, affiliate, partner, and vendor medical reviewers to drive alignment, knowledge sharing, and process consistency.
- Supports vendor oversight activities for the Medical Review function, including performance monitoring, issue management, and ensuring compliance with company and regulatory expectations.
- Monitors and evaluates the safety profile of assigned products through medical assessment of safety data, emerging risks, adverse event trends, and benefit-risk considerations in accordance with global regulatory requirements.
- Partners with Medical Safety Product Leaders and provides Medical Review input during safety governance, labeling, and cross-functional discussions involving emerging safety information.
- Performs review and approval of the MedDRA coding activities.
- Maintains current knowledge of evolving pharmacovigilance regulations, industry standards, and best practices related to signal detection, risk management, and risk communication.
- Performs ongoing review and analysis of adverse event data to identify potential safety signals, trends, and areas requiring further assessment.
- Escalates significant safety concerns, quality issues, compliance risks, and emerging safety findings through appropriate pharmacovigilance governance channels.
- Collaborates closely with PV Operations, Safety Data Management, Compliance Business Management, Medical Safety Product Leaders, and other Global Pharmacovigilance functions.
JOB SCOPE (key facts & figures)- Being available on-site to support business needs and able to travel, including internationally (up to 15%) as required.
- Global role which requires after-hours meetings with Japan.
QUALIFICATIONS/ EXPERIENCE REQUIREDEducation and Related Experience- M.D. from an accredited medical school with at least 5+ years of Safety Surveillance experience in pharmaceutical industry
- Experience with both development and product launch/post marketed products.
- Experience interacting with global regulatory authorities such as EMA, MHRA, PMDA, Health Canada.
- Prior supervisory and vendor oversight experience
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.
- Experience supporting interactions with global regulatory authorities and representing inspections
- Solid knowledge of 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.
COMPETENCIES REQUIRED- 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.
CompetenciesAccountability 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 $186,489.00 - Maximum $278,875.00, 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.
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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.
