Patient Safety Regional Service Director (JPN)

Job Title: Patient Safety Regional Service Director (JPN)

Career Level: F

Introduction to role:

Are you ready to make a significant impact on patient safety in Japan? AstraZeneca is on a mission to improve the lives of 200 million patients by delivering 20 new medicines by 2030. As the Patient Safety Regional Service Director, you'll play a pivotal role in achieving this bold ambition. Join our Global Business Services (GBS) team, where we're enhancing customer focus and establishing Research & Development Services to drive AstraZeneca's vision forward. This role is your opportunity to lead and manage our GBS Patient Safety Hub in Japan, ensuring excellence in pharmacovigilance processes and contributing to AstraZeneca's growth.

Accountabilities:

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, being responsible for 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.
• Track and analyze case intake metrics for the Japan Hub, preparing reports on benchmarks and identifying areas for progress.
• Annual update and testing of local Business Continuity Process (BCP).
• Implementing and being responsible for 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 exchange guidelines.
• Collaborate closely with internal team members to expand and improve the function to align with the broader GBS Business objectives.

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.

Essential Skills/Experience:

• Education: Degree in relevant field or equivalent experience.
• Minimum of 7-10 years of experience in pharmacovigilance, with at least 2-5 years in a leadership role.
• In-depth knowledge of global and regional pharmacovigilance regulations.
• Experience in delivering wide-scale transformation change programmes and projects.
• Knowledge of key industry standards and regulations that influence Global Patient Safety.
• Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines.
• Excellent leadership and team management skills, with the ability to motivate and develop staff in a multicultural environment.
• Strong analytical and problem-solving skills, with the ability to interpret data and drive process improvements.
• Strong communication skills, including writing and speaking, to engage effectively with internal and external collaborators in various regions.
• Ability to work within a complex matrix / works collaboratively.
• Exceptional attention to detail and commitment to maintaining high-quality standards.

Desirable Skills/Experience:

• Education: Higher Degree (MBA, PhD) preferred in relevant field.
• Proficiency in safety databases, ideally Argus, and case management systems.
• Track record in managing and optimising Patient Safety processes.

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll be part of a dedicated distributed team that drives our evolving enterprise. We leverage exciting new technology and digital innovations to accelerate our evolution. With an entrepreneurial spirit, we apply creativity to every task we do. Our fast-paced environment is ideal for ambitious self-starters who aim to add customer value. You'll have countless opportunities to build an unrivalled reputation while contributing to something bigger—making a difference in patients' lives.

Ready to take on this exciting challenge? Apply now and be part of our journey!