【AstraZeneca】【GBS-PS】Local Case Intake Team Manager,Global Business Services

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About the role

Role Profile  The Local Case Intake Team Manager is responsible for overseeing the local case intake process for Japan regulatory reporting, ensuring efficient and compliant handling of adverse event reports.  This role requires strong leadership skills, in-depth knowledge of pharmacovigilance regulations, and the ability to manage a team in a fast-paced environment. This Team Manager will manage the team responsible for local case intake activities for Japan regulatory reporting as determined by the GBS PV Strategy and Operating Model. This Team Manager will be fluent in Japanese as well as in English (see Essential). Key responsibilities include: •    Leading and managing a local case intake team, providing guidance, training, and performance management to ensure high-quality standards in case processing •    Overseeing the intake, processing, and reporting of Individual Case Safety Reports (ICSRs) in compliance with the appropriate pharmacovigilance regulations and AZ standards •    Ensuring timely and accurate processing of information for all patient safety cases.  •    Overseeing Health Authority interactions, ensuring that Local Case Intake Advisors are delivering this aspect of their role and acting as an escalation point where Health Authority interactions require more senior involvement •    Monitoring and analysing local case intake metrics for the local case intake team, preparing reports on key performance indicators (KPIs) and identifying areas for improvement •    Staying updated on changes to local and global pharmacovigilance regulations, ensuring consistency between global and local processes as well as implementing and maintaining standard operating procedures (SOPs) for the latter •    Participate in audits and inspections, ensuring the local case intake process is audit-ready •    Conducting quality checks on completed cases to verify accuracy, consistency, and compliance with all requirements •    Serving as a liaison between local and global levels, communicating changes related to the local pharmacovigilance organisation •    Participating in ad-hoc Global, Regional, or local MC case handling projects Accountabilities & Responsibilities The Core responsibilities include: •    Maintain in-depth knowledge of the local health authority regulations and update local teams with any new changes in legislation/guidance for discussion and escalation to relevant stakeholders in Global Patient Safety as required. •    Ensure that local procedural documents/ standard operating procedures are followed for reporting/processing/ translation of AEs and are up to date & available for any patient safety audit and inspection. •    Support where necessary local maintenance activities relating to the Pharmacovigilance System Master File (PSMF) •    Maintain oversight of all patient safety-related processes for Japan regulatory reporting •    Maintain current knowledge of the marketed status of products in the local country and reference documents (such as Product Information/Datasheet) •    Support full and prompt response to any patient safety query from the local regulatory authority related to patient safety function as determined by GBS and AstraZeneca agreed KPIs and SLAs •    Participate in audits and inspections, ensuring the local case intake process is audit-ready •    Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority •    Support local safety management agreements to fulfil AstraZeneca and local regulatory safety reporting requirements  •    Ensure cross-function collaboration through sharing patient safety knowledge with the Japan MC teams (e.g., Japan Patient Safety, Sales, Regulatory Affairs, Medical Affairs; refer to Key Relationships

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