Medical Information Manager

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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The Medical Information Manager is responsible for ensuring high-quality compliant and timely responses to external medical inquiries across all therapeutic areas in Japan. This role serves as the primary escalation contact for complex medical inquiries that cannot be addressed by the external vendor (PPG) and ensures the scientific accuracy regulatory compliance and consistency of all medical information communications.

The position is also responsible for vendor oversight quality control in MISTRAL management of Standard Response Documents (SRDs) reconciliation of safety information and governance of Medical Information processes in compliance with local regulations and Ipsen global standards. All activities must adhere to Ipsen SOPs PV requirements GVP and applicable regulatory and compliance frameworks.

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.

Knowledge & Experience

• 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
• Strong scientific writing skills
• Regulatory knowledge (PMDA GVP PV requirements)
• Vendor oversight capability
• Process governance and documentation management
• Detail-oriented quality mindset
• Project management skills

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