Sr. Manager, Patient Safety (Minato-ku, Tokyo-To, JP)

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.

Education / Certifications:

• Bachelor's degree in pharmacy, life sciences, nursing, public health, or related field required. Advanced degree (MSc, PhD, PharmD) preferred.

• Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) training.

Experiences

• Minimum 10 years of pharmacovigilance experience in the pharmaceutical or biotechnology industry, with substantial exposure to Japan-specific PV regulations (GCP,GVP).

• Demonstrated experience interacting with the PMDA and supporting regulatory inspections.

• Proven track record in managing outsourced pharmacovigilance operations, including CRO/vendor oversight, case processing quality management, and PVA governance.

• Experience contributing to or leading the preparation of J-RMPs, aggregate report including J-DSURs, J-PSURs, re-examination dossiers, and safety sections of regulatory submissions.

• Strong understanding of global pharmacovigilance frameworks (ICH, EU GVP) and how they interface with Japanese requirements.

• Prior experience in a Deputy Anseki or equivalent safety-responsible backup role is strongly preferred.

• Experience supporting safety operations during product launches, including EPPV and post-marketing surveillance (PMS), is a distinct advantage.

Competencies:

• Regulatory and Scientific Expertise: Deep working knowledge of GVP, GCP, and global pharmacovigilance regulations, combined with the ability to interpret and apply complex regulatory requirements in practical operational contexts.

• Oversight and Process Thinking: Strong orientation toward process governance, vendor management discipline, and continuous improvement in how pharmacovigilance operations are structured and executed.

• Curiosity and Strategic Maturity: Demonstrates an open-minded approach to emerging and evolving situations and actively explores how Patient Safety can contribute. Ability to think beyond day-to-day operations and contribute to the broader strategic direction of the Patient Safety function, with the judgment and confidence to serve as a credible sparring partner to the function head.

• Flexible mindset: Demonstrates a flexible mindset, with the ability to generate multiple approaches to demonstrating compliance with both Japan and global requirements, and to make optimal, situation-appropriate judgments.

• Independence and Accountability: Capable of operating with limited supervision, taking ownership of deliverables, and making sound decisions under time pressure

in a organizational environment.

• Cross-functional Collaboration: Effective at working across functional boundaries with Clinical Development, Regulatory Affairs, Product Quality, and Medical Affairs, and across organizational boundaries with global Patient Safety counterparts.

• Communication: Strong written and verbal communication skills in both Japanese and English, with the ability to present complex safety information clearly to internal stakeholders and regulatory authorities.

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