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 REQUIRED

Education 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. 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 $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. Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .

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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. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting EEAccommodations@otsuka-us.com . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (\"Otsuka\") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. 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Associate Director, Global Medical Review