Purpose of the job:
This role is a critical addition to Lundbeck Japan's Drug Development organization, reporting to the Head of Patient Safety Japan. The individual will serve as a senior pharmacovigilance professional responsible for supporting the safety oversight of Lundbeck's expanding product portfolio in Japan, including both marketed products and pipeline assets approaching regulatory milestones. The role is positioned at a level where the successful candidate would be expected to develop toward readiness for broader safety-responsible leadership, including eligibility for the Deputy Anseki designation under the PMD Act and J-GVP regulations. This requires someone who combines deep pharmacovigilance expertise with the independence, judgment, and collaborative approach needed to contribute meaningfully in a lean and growing organization.


Responsibilities:
• Serve as the primary backup to the Head of Patient Safety Japan, including acting as Deputy Anseki when required.
• Exercise independent and accountable judgment on safety-related matters in accordance with Japan regulatory requirements, global pharmacovigilance standards, Anseki’s direction. and company strategy.
• Provide safety oversight across Lundbeck Japan's portfolio, including marketed products and clinical-stage assets, ensuring compliance with J-GVP and applicable global pharmacovigilance regulations.
• Manage and oversee relationships with external vendors responsible for case processing, safety database operations, and related outsourced pharmacovigilance activities, ensuring contractual compliance, data quality, and timely regulatory reporting.
• Maintain, and oversee safety operational process governance, including the maintenance of local QMS documents and Pharmacovigilance agreement(PVA) or Safety Data Exchange Agreements (SDEAs) with third parties .
• Contribute to the establishment and maintenance of Japan Risk Management Plans (J-RMPs), including risk minimization strategies and Early Post-marketing Phase Vigilance (EPPV) activities for new product launches collaborating with global and local stakeholders.
• Interface with the PMDA on safety-related matters, including support for regulatory inspections, GVP self-inspections, and responses to regulatory inquiries.
• Collaborate with global Patient Safety counterparts to ensure alignment on signal detection, benefit-risk assessment, aggregate reporting, and safety data exchange.
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Product Quality, and Medical Affairs to ensure integrated safety input across development and commercial activities.
• Provide scientific and strategic input on safety-related components of regulatory submissions, in collaboration with global Patient Safety, including contributions to J-NDA safety sections, J-DSURs, J-PSURs, and re-examination dossiers.
• Identify and drive continuous improvement in pharmacovigilance systems within the Japan Patient Safety function.


Tasks:
• Provide managerial oversight of pharmacovigilance operations as Deputy Anseki when required, including supervision of team activities and end-to-end oversight of safety processes, to ensure regulatory compliance, quality, and operational effectiveness.
• Conduct review and quality oversight of Individual Case Safety Reports (ICSRs) from both post-marketing and clinical trial sources in accordance with Japan regulatory requirements, ensuring accuracy, completeness, and appropriate judgement.
• Prepare, review, and ensure timely submission of periodic safety reports (J-PSURs, J-DSURs) and annual infection reports as required.
• Develop and maintain inspection-readiness documentation and support the execution of internal self-inspections and external regulatory audits.
• Establish and manage post-marketing safety activities (including postmarketing surveillance, clinical research, market research, and patient support programs) in compliance with pharmacovigilance requirements, in collaboration with relevant internal functions and vendor staff.
• Support launch readiness activities for new products by contributing to safety planning, and EPPV design.
• Monitor regulatory developments and evolving PMDA expectations related to pharmacovigilance and drive operational or procedural adjustments.