Location: Bengaluru, Karnataka
🏢 Industry: MNC BPO
💼 Job Type: Full-Time
💰 CTC: ₹18 – ₹22 LPA
👥 Open Positions: 2
🔍 Role Overview
We are hiring an experienced Japanese Language Expert with a strong background in Pharmacovigilance (PV) to join a leading MNC BPO. The ideal candidate will have expertise in Japan PV processes, stakeholder management, and bilingual communication in Japanese and English.
✅ Key Responsibilities
Manage the complete Japan PV case processing lifecycle (intake, triage, data entry, translation, QC, and reporting).
Handle ICSR case processing and reporting.
Ensure compliance with PMDA, J-GVP, ICH, GVP, and other global pharmacovigilance regulations.
Act as the primary point of contact for Japan stakeholders and global PV teams.
Lead governance calls, client interactions, and escalation management.
Drive audit readiness, inspections, CAPA, deviations, and quality initiatives.
Mentor and manage bilingual (Japanese-English) Pharmacovigilance teams.
Conduct performance reviews, training, and knowledge-sharing sessions.
Identify process improvements, automation opportunities, and productivity enhancements.
Perform RCA and implement CAPA frameworks to maintain quality standards.
🎯 Required Skills
✔️ 7–11 years of experience in Pharmacovigilance
Hands-on experience with:
ICSR Case Processing & Reporting
Japan PV Processes (Domestic & Foreign Cases)
Safety Databases (Argus, ArisG, Veeva Safety, etc.)
Strong knowledge of:
ICH Guidelines
Global PV Regulations
Japan HA Reporting
J-GVP Requirements
✔️ Excellent analytical, stakeholder management, and communication skills.
🗣 Language Requirement
Japanese: JLPT N3 or above (Minimum N3)
Strong ability to read, write, and communicate clinical and regulatory content in Japanese and English.
🎓 Education
Bachelor’s Degree (Any Discipline)
B.Pharm preferred
📩 Interested candidates, share your updated resume at:
📧 [email protected]
📱 WhatsApp / Call: 9356177229 / 9970500910
Know someone who fits this role? Tag them or share this opportunity with your network!