Local Case Intake Service Manager

The Local Case Intake Service Manager – China is responsible for overseeing the local case intake service in China, 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 of service providers in a fast-paced environment. 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. • 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 • 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 • Managing service vendors and outsourced service providers (OSPs), including performance oversight, issue escalation and delivery against agreed service levels • Participating in ad-hoc Global, Regional, or local MC case handling projects Accountabilities & Responsibilities • Maintain in-depth knowledge of the local health authority regulations and update regional lead & 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 local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF) • Support the maintenance of local case intake and associated operational PV services processes • 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. • Facilitate the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority. • Support implementation and operational execution of local safety management agreements and clinical study protocols to fulfil AstraZeneca and local regulatory safety reporting requirements. • Ensure timely submission of ICSR, follow-up cases, and other safety documents to local health authorities. • Support Health Authority interactions and queries for ICSR handling related queries • Ensure corrective and preventative actions are taken in the event of local non-compliance or breach of agreed SLAs. • Support assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the AstraZeneca Always Serious List. • Support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements. • Establi