Director, Medical Devices, Diagnostics and Digital Medicine Safety, GPV

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Job description

As a member of the Global Pharmacovigilance (GPV) department, the Director, Medical Devices, Diagnostics and Digital Medicine Safety responsibilities include but is not limited to the management of device, digital and diagnostic processes. He/ She will serve as an expert in medical device, combination product, diagnostics and digital medicine safety, providing guidance, oversight, and content contributions related to all aspects of pharmacovigilance. This position will support business process and oversee safety information evaluation for complaint handling, health authority reporting of MDRs, clinical development of devices, combination products, diagnostics, and digital medicine products. The Director, Medical Devices, Diagnostics and Digital Medicine Safety will ensure collaboration and communication with multiple stakeholders internally, externally, and with vendor(s) to ensure compliance and high[1]quality standards are met. The individual in this position must be able to manage multiple tasks simultaneously and prioritize competing requests or projects. Key Job Responsibilities. Responsible for the management of procedures related to devices, digital and diagnostic including process creation, implementation, communication, performance and inspection readiness. Ensure that internal processes are fit for purpose and maximize the effectiveness of the outsourced delivery, working with relevant stakeholders to improve processes. Responsible for the overall management of medical device, diagnostic and digital vigilance system including ensuring robust oversight mechanism in place with our outsourced vendors to monitor the daily intake, evaluation, processing, and follow-up of reports from medical devices, combination products, diagnostics, and digital therapeutics, complying with government regulations to ensure continued compliance. Ensures complete and accurate maintenance and oversight of reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Act as SME, providing guidance and content contribution to project teams on various deliverables including but not limited to protocol development, safety reporting, trending, analysis of data, and post market surveillance. Escalate issues to GPV management and collaborate with cross functional teams to coordinate and track to resolution issues in a timely manner. Participate in health authority query responses as needed. Manage PV vendor management oversight activities related to device, diagnostic and digital vigilance. Support and improve device vigilance complaint handling activities and procedures. Ensure compliance with procedures and reporting timelines. Provide expert operational / strategic input and guidance to cross-functional teams e.g. Quality, Compliance, and Digital Medicine functions. Engage and influence internal and external key stakeholders to drive the strategy, development and. continuous improvement of processes, technology and services within Device, Digital and Diagnostic area. Coordinate the development and delivery of training materials. Ensure adequate training and mentoring is available. Leverage MDR case assessment expertise and in collaboration with Product Medical Directors to ensure quality assessments. Manage the review of documents related to MDR case processing and reporting such as Safety Management Plans, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions etc. Drive initiatives to improve quality of MDRs and compliance. Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties. Interact with Inspectors during health authority inspections and ensure timely responses to inspection requests. Participate in the development and maintenance of policies, SOPs, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines and industry best practices. Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes. Support GPV compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements. Perform other tasks as assigned by the management of global PV. Required Knowledge, Skills, Competencies, Education, and Experience. Knowledge. Strong background in medical device complaint handling. Strong understanding of medical device regulations and industry standards globally (e.g. 21 CFR 820, 803, and EU MDR 2017/745). Knowledge of the ARGUS Safety Database. Knowledge and prior experience in case processing desired. Knowledge of the interworking's of Global Pharmacovigilance organization is desired. Experience with managing vendors, partners, and/or CRO's preferred. Skills. Excellent problem solving, strategic decision-making and analytical skills. Strong communication and writing skills. Ability to work both independently and lead cross functionally, without authority in some circumstances, across GPV, Quality, Regulatory, Clinical Development, and Clinical Management, as well as other applicable functions within Otsuka. Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Knows how/when to apply organizational policy or regulatory procedures to a variety of situations. Ability to work under pressure to meet tight timelines. Able to work effectively in a matrix environment. Strong attention to detail along with the ability to problem solve. The ability to provide direction to a team, and to influence peers and team members appropriately preferred. High level of accuracy, integrity, and quality in work practices. Education and Related Experience. A minimum of a bachelor's degree is required. RN, NP, PA, PhD, or Pharmacist (RPh/PharmD) with 3 or more years of drug safety experience or bachelor's degree in a life science field or equivalent, with 5 years or more of drug safety experience in the pharmaceutical industry. Physical Demands and Work Environment. Occasional teleconferencing at off business hours resulting from meetings being held with US and Japan. Approximately 15-20% travel within US, EU, Asia, and Japan. 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. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status. Statement Regarding Job Recruiting Fraud Scams. Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. 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