Work Location , Expected Annual Income :
Tokyo,10.0M ～ 13.0M
About the Company :
Global European Pharmaceutical Company
Responsibilities :
Responsibilities include, but are not limited to:
Medical Inquiry Management
- Act as the escalation point for complex medical inquiries received via PPG.
- Provide scientifically accurate, balanced, and compliant responses in alignment with local regulations and global guidance.
- Ensure appropriate documentation of inquiries and responses in MISTRAL.
Quality Control & Systems Oversight
- Perform quality control (QC) of cases in MISTRAL.
- Ensure completeness, accuracy, and regulatory compliance of case documentation.
- Monitor KPIs and quality metrics of Medical Information processes.
Standard Response Document (SRD) Management
- Develop, update, and maintain Standard Response Documents (SRDs).
- Ensure alignment with global medical information content.
- Coordinate local adaptation and approval processes.
Vendor Management (PPG)
- Serve as primary liaison with PPG.
- Oversee vendor performance and quality metrics.
- Lead regular operational meetings.
- Manage contractual documentation (PVA, SOPs, EHS, Quality Agreements).
- Ensure continuous improvement of vendor processes.
Safety & Compliance Oversight
- Conduct weekly AE and PQC reconciliation with PPG.
- Ensure timely and accurate reporting of safety information in compliance with local PV requirements (JGVP).
- Collaborate closely with PV team.
Governance & Documentation
- Maintain and update local MI SOPs.
- Ensure compliance with PVA, EHS, and global medical information standards.
- Support audits and inspections related to Medical Information activities.
Cross-Functional Collaboration
- Partner with Regulatory, PV, Legal, Compliance, Commercial, and Global Medical Information.
- Provide internal training on Medical Information processes when required.
Benefits :
Employment Type: Full time employee
Office Location: Tokyo, Japan
Working Model: Hybrid
Interviews: 3
Welfare and Insurances: All covered
Budget: Up to 13mil (Base + Bonus)
Required Experience / Abilities / Skills :
- Biomedical / Scientific degree (PharmD, MSc, PhD preferred)
- 5+ years experience in Medical Information, Medical Affairs, or Pharmacovigilance
- Experience in vendor management preferred
- Experience with medical information systems (MISTRAL preferred)
- Strong knowledge of Japanese regulatory and PV requirements (JGVP)
- Experience with SOP development and quality oversight
- Fluent Japanese and strong scientific English proficiency