Company overview:
A global provider of specialized consulting, regulatory, and scientific services to the pharmaceutical, biotech, and medical device industries. The organization helps clients navigate complex regulatory environments, ensuring compliance, quality, and efficient product development. It combines deep technical expertise with strategic guidance to support successful market entry and lifecycle management.
Key Responsibilities
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Medical Information Support: Provide both approved and non-approved medical and safety-related information in compliance with industry regulations and company policies.
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Inquiry Management: Respond to medical and safety-related questions from healthcare professionals, patients, and consumers via phone, email, and online channels.
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Adverse Event & Product Complaint Reporting: Identify, document, and report adverse events, pregnancy-related cases, special situation reports, and product complaints, ensuring compliance with regulatory requirements, internal SOPs, and client-specific guidelines.
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Medical Content Development: Use approved product information, standard response documents, published literature, and internal clinical data to deliver accurate, scientifically sound responses; draft and customize response documents for external inquiries.
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Data Protection & Compliance: Follow company and country-specific data protection policies.
Required Qualifications
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Licensed Pharmacist in Japan (必須 – Required)
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Native-level Japanese and business-level English proficiency
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Strong understanding of medical terminology, pharmacology, and regulatory standards
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Ability to analyze scientific data and provide accurate, well-structured responses
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Excellent communication skills, providing clear and empathetic medical information
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Receptive to feedback and proactive in pursuing improvements
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Self-motivated and able to work independently, including in remote settings