Local Case Intake Team Manager

Job Title: Local Case Intake Team Manager

Career Level- D

Introduction to role:

Are you ready to lead a team that plays a crucial role in ensuring patient safety? As the Local Case Intake Team Manager, you will oversee the local case intake process for Japan regulatory reporting, ensuring efficient and compliant handling of adverse event reports. This position demands strong leadership skills, a deep understanding of pharmacovigilance regulations, and the ability to manage a team in a fast-paced environment. Fluent in both Japanese and English, you will guide your team to achieve high-quality standards in case processing and regulatory compliance.

Accountabilities:

• Lead and manage a local case intake team, providing guidance, training, and performance management.

• Oversee the intake, processing, and reporting of Individual Case Safety Reports (ICSRs) in compliance with pharmacovigilance regulations and AstraZeneca standards.

• Ensure timely and accurate processing of information for all patient safety cases.

• Monitor and analyze local case intake metrics, preparing reports on key performance indicators (important metrics) and identifying areas for improvement.

• Stay updated on changes to local and global pharmacovigilance regulations, implementing and maintaining standard operating procedures (SOPs).

• Participate in audits and inspections, ensuring the local case intake process is audit-ready.

• Serve as a liaison between local and global levels, communicating changes related to the local pharmacovigilance organization.

• Participate in ad-hoc Global, Regional, or local MC case handling projects.

Essential Skills/Experience:

• Degree Qualified – Pharmacy/ Medical/ Science

• Proven track record of team management (2-5 years)

• Life-science background

• 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 organizational 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 Skills/Experience:

• Higher Degree (MBA, PhD) preferred in relevant field

• Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry

• Thorough knowledge of the current pharmacovigilance and regulatory developments

When we put unexpected teams in the same room, we unleash 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 global team that powers our enterprise to better serve patients every day. We thrive in a dynamic environment where creativity meets critical thinking. With exciting technology and digital innovations at our fingertips, we motivate change that impacts patients' lives worldwide. Here, you'll find countless opportunities to grow your career while contributing to something bigger.

Ready to make a difference? Apply now and join us on this exciting journey!

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.