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 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
 

Education, Qualifications, Skills, and Experience

Essential

・Degree Qualified – Pharmacy/ Medical/ Science
・Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry
・Thorough knowledge of the current pharmacovigilance and regulatory developments
・Ability to work in a fast-paced environment and meet tight deadlines
・Excellent leadership and team management skills, with the ability to motivate and develop staff in a multicultural environment
・Experience in working cross-functionally 
・Ability to set and manage priorities, resource goals and project initiatives
・Ability to influence strategically to obtain desired outcomes while maintaining effective, positive organisational relationships
・Excellent attention to detail
・Excellent written and verbal communication skills
・Japanese language proficiency Test (JLPT): N2 or higher
・English language proficiency: B1 Threshold based on Common European Framework Reference for Languages (CEFR)

Desirable

・Higher Degree (MBA, PHD) preferred in relevant field

Key Relationships to Reach Solutions
Internal (to company or team)

・Japanese Facilities Team
・Global / Japan Patient Safety
・R&D Global / Japan Functional Teams – including but not limited to Site management and Monitoring (SM&M), Clinical Operations, Regulatory Affairs
・R&D Transformation management, teams
・Medical Information 
・Global / Japan Business Units
・Global / Japan Medical Affairs
・Commercial Services including Digital, Procurement, and Business Development
・Corporate Communications
・Quality Assurance Management
・Legal & Privacy
・Global / Japan R&D IT
・Global / Japan HR
 

External (to company)

External Service Providers 
License Partners
Healthcare professionals
Health Authorities
Professional societies or organisations
Other local and global stakeholders 
 

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.