【AstraZeneca】【GBS-PS】Patient Safety Regional Service Director, Japan

Regulatory Compliance

• Ensure compliance of all activities, particularly local case intake, with global and Japan regulatory requirements, including timely submission of appropriate Regulatory Reports
• Serve as a subject matter expert during audits and inspections related to case intake relevant processes within the hub

Leadership & Team Management

• Maintain appropriate staffing levels in the hub, overseeing recruitment of new staff where required
• Ensure that training and development of GBS PS staff results in consistent and compliant knowledge and skills within the hub
• Lead and manage the Team Managers and Case Intake, Training, Quality & Compliance, Regulatory Reporting and Literature Review teams, ensuring appropriate guidance, training, and performance management to maintain high-quality standards

Service Delivery & Process Improvement

• Oversee the daily operations of the hub, ensuring efficient processing and reporting of adverse event cases, Literature Reviews and Regulatory Reporting activity within Health Authority timelines
• Monitor and analyse case intake metrics for the Japan Hub, preparing reports on KPIs and identifying areas for improvement
• Annual update and testing of local Business Continuity Process (BCP)
• Implementing and overseeing quality management systems, procedural documents, and staff training to ensure high-quality and compliant operations
• Leading the reporting and investigation of any quality incidents related to pharmacovigilance processes within the region
• Implement and maintain standardised operating procedures (SOPs) for case intake processing, Literature Reviews and Regulatory Reporting, ensuring consistency with global pharmacovigilance practices
• Contribute to the development and optimisation of all global and Japan patient safety processes, systems and tools, including automation solutions

Relationship Management

• Collaborate with other GBS Patient Safety Regional Service Directors and the Global/Japan Patient Safety (GPS) team to improve processes and share best practices
• Work closely with internal stakeholders to grow and develop the function to support and enhance the wider GBS Business goals

General

• Dedicate time to self-development to ensure industry knowledge is kept up to date and personal objectives are achieved
• Work closely with GBS R&D Teams in the successful design and delivery of Business projects
• Stay updated on regional and global pharmacovigilance regulations for those MCs supported by the Japan Hub, ensuring that necessary changes are implemented to maintain compliance
• Performs other related duties as assigned or requested per business needs
• Review of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations
• Ensure delivery of services meets or exceeds SLAs 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

Closing Date

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.