【AstraZeneca】【GBS-PS】Local Case Intake Team Manager

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 to Reach Solutions)
• Ensure timely submission of ICSR, follow-up cases, and other safety documents to local health authorities
• Ensure corrective and preventative actions are taken in the event of local non-compliance or breach of agreed SLAs.
• If required, support review of medical and scientific literature to identify possible Adverse events in accordance with AstraZeneca and local regulatory pharmacovigilance requirements
• Establish strong relationships and effective cross-function collaboration with regulatory, marketing, medical, and other internal and external stakeholders’ functions to deliver patient safety requirements for business and regulatory needs (refer to Key Relationships to Reach Solutions)
• Ensure that the local case intake team completes all required patient safety training, Global and local PS systems (e.g. Argus) and adheres to internal processes and external regulations.  Act as a mentor to support newly appointed Case Intake Advisors
• Ensure an after-hours process is in place and maintained, to ensure a customer can report an AE and respond to regulatory authority questions
• Oversee filing and archiving practices of patient safety documents
• Manage patient safety compliance data for the case intake team is up-to-date (e.g. monthly)
• Ensure appropriate Local Case Intake Advisor cover is in place so that all activities continue to be performed within the required timeframes when out of the office, on holiday, unexpected leave etc
• Support patient safety projects at local & global levels
• Leading the reporting and investigation of any quality incidents related to processes within the local case intake team
• Performs other related duties as assigned or requested per business needs
• Training and mentoring of staff on safety information pertaining to Intake, Literature reports and regulatory reporting processes
• Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations
• Ensure delivery of services meets or exceeds Service Level Agreements through focused metrics management of process performance
• Generate reports, use Management Information System, and/or provide updates on service delivery, employee engagement, process improvements, etc. for timely reporting and enable decision making

Date Posted

16-Oct-2025

Closing Date

30-Jan-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.