What would you do? 

• Strong understanding of global PV regulations (ICH, GVP, PV guidelines)
• Expertise in Japan HA reporting and J GVP requirements
• Stakeholder and client management (Japan-facing)
• Analytical thinking, risk management, and decision-making
• High attention to detail and quality orientation
• Excellent communication (Japanese & English)

Customer service refers to the assistance and support provided by a business or organization to its customers before, during, and after a purchase or use of a product or service. It involves addressing inquiries, resolving issues, and ensuring customer satisfaction to build and maintain positive relationships.
What are we looking for? 

Hands-on experience in: 
• ICSR case processing & reporting
• Japan PV processes (foreign/domestic cases)
• Safety databases (Argus, ArisG, Veeva Safety, etc.)
Language Expertise
• Japanese Language: JLPT Minumum N3
• Strong ability to read/write clinical and regulatory content in Japanese 
 

Roles and Responsibilities: 

•ü Manage Japan PV case processing lifecycle (intake, triage, data entry, translation, QC, reporting)
ü Ensure adherence to SLAs, quality benchmarks, and regulatory timelines
ü Ensure alignment with Japan HA requirements (PMDA, J GVP)
ü Drive audit readiness, inspection support, CAPA and deviations
ü Act as primary interface for Japan stakeholders and global PV teams
ü Lead governance calls, performance reviews, and escalation management
ü Lead and mentor bilingual (Japanese-English) PV teams, Performance management.
ü Drive training, knowledge management, and skill development
ü Drive continuous improvement, productivity, and cost optimization and automation.
ü Maintain quality standards in case processing as per client requirements.
ü Monitor trends, perform RCA, and implement CAPA frameworks

Education :

Any Graduation,Bachelor of Pharmacy