Assistant Manager- Japanese Language Local Case Intake Manager

Responsibilities

• Lead, coach, and develop a team of Local Case Intake Advisors to ensure high-quality case intake and processing.
• Oversee the timely and accurate intake, processing, and submission of Individual Case Safety Reports (ICSR) in compliance with regulations.
• Maintain detailed knowledge of local pharmacovigilance regulations and align local practices with global standards.
• Coordinate and guide responses to Health Authority queries to protect compliance and credibility.
• Conduct quality checks and drive corrective and preventive actions to address findings and prevent recurrence.
• Track and analyze operational metrics to improve efficiency, quality, and cycle times.
• Build positive relationships with medical, regulatory, and commercial teams to deliver on safety and business needs.
• Ensure accurate contributions to the Pharmacovigilance System Master File (PSMF).

Requirements

• Degree in Pharmacy, Medical, or Science.
• Proven pharmacovigilance experience within the pharmaceutical industry.
• Thorough knowledge of current pharmacovigilance and regulatory developments.
• Experience working in cross-functional environments.
• Strong written and verbal communication skills with excellent attention to detail.
• Ability to set and handle priorities, resource goals, and project initiatives.

Preferred Qualifications

• Experience leading and mentoring local case intake teams in a fast-paced environment.
• Hands-on experience with global patient safety systems (e.g., Argus).
• Proven track record of supporting audits and maintaining inspection readiness.
• Direct experience managing Health Authority interactions and sophisticated safety queries.
• Experience with SOP design, implementation, and lifecycle management.

Benefits

• Lifelong learning opportunities including leadership projects and global collaboration programmes.
• Autonomy to shape your career and make significant decisions.
• Focus on health and wellbeing with support for physical, financial, and psychological needs.
• A culture that prioritizes diversity, inclusion, and respect.

About the Company

AstraZeneca is a global, science-led biopharmaceutical company that aims to deliver life-changing medicines. We push the boundaries of science to tackle some of the world's most complex diseases, fostering a culture of innovation, collaboration, and integrity.