Job Title: Patient Safety Regional Service Director – Japan (JPN)
Location: Bangalore, India
Employment Type: Full-Time
Application Deadline: 23rd December 2025
Job Requisition ID: R-237235
AstraZeneca is seeking a highly experienced Patient Safety Regional Service Director to lead its Global Business Services (GBS) Patient Safety Hub in Japan. This strategic leadership role offers the opportunity to shape pharmacovigilance operations, ensuring compliance, process excellence, and patient safety in line with AstraZeneca’s mission to improve the lives of 200 million patients and deliver 20 new medicines by 2030.
As a key member of the GBS team, you will oversee case intake, regulatory reporting, literature review, and quality management processes while driving operational improvements and team development. This role is ideal for a seasoned pharmacovigilance professional with proven leadership experience and a strong understanding of global and regional safety regulations.
Regulatory Compliance
Ensure adherence to global and Japan-specific pharmacovigilance regulations.
Act as subject matter expert during audits and inspections relating to case intake processes.
Leadership & Team Management
Lead and manage Team Managers across Case Intake, Training, Quality & Compliance, Regulatory Reporting, and Literature Review functions.
Drive recruitment, staff development, and performance management to maintain high-quality standards.
Foster a collaborative, multicultural team environment.
Service Delivery & Process Optimization
Oversee daily operations of the Japan hub, ensuring timely and accurate processing of adverse event cases, literature reviews, and regulatory reports.
Implement and maintain SOPs, quality management systems, and process improvements aligned with global pharmacovigilance practices.
Track key metrics and generate reports to support performance monitoring and decision-making.
Lead business continuity planning and quality incident investigations.
Contribute to automation and process optimization initiatives across global and regional patient safety operations.
Stakeholder & Relationship Management
Collaborate with internal GBS teams and global Patient Safety counterparts to optimize processes and share best practices.
Partner with R&D and cross-functional teams to support business objectives and ensure compliance with regional and global safety regulations.
Continuous Learning & Development
Stay updated on regional and global pharmacovigilance regulations.
Dedicate time to personal development and continuous improvement initiatives.
Bachelor’s degree in a relevant field (Pharmacy, Life Sciences, Medicine, or equivalent).
7–10 years of pharmacovigilance experience, including 2–5 years in a leadership role.
In-depth knowledge of global and regional pharmacovigilance regulations.
Proven experience managing large-scale transformation programs and process improvements.
Strong analytical, problem-solving, and decision-making skills.
Excellent leadership and team management abilities, with experience motivating multicultural teams.
Strong communication and interpersonal skills to engage with internal and external stakeholders.
Ability to thrive in a fast-paced, matrix environment and manage multiple priorities efficiently.
Exceptional attention to detail and commitment to high-quality standards.
Desirable Qualifications & Experience
Advanced degree (MBA, PhD) in a relevant field.
Proficiency in safety databases, particularly Argus, and case management systems.
Track record in optimizing patient safety processes and delivering measurable outcomes.
At AstraZeneca, you will be part of a dynamic, innovative environment where your contributions directly impact patient lives globally. We embrace diversity, inclusion, and collaboration, enabling employees to thrive while driving meaningful change. This role offers flexibility, professional growth, and the chance to work on groundbreaking projects that shape the future of healthcare.
How to Apply:
Interested candidates are invited to submit their application before 23rd December 2025. Be part of AstraZeneca’s journey to redefine patient safety and make a tangible impact on global health.
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