Pharmacovigilance Scientist, Global Patient Safety Japan

Position Overview

A global biopharmaceutical company is seeking an experienced Pharmacovigilance Scientist to join its Global Patient Safety team in Japan. This highly visible role involves scientific leadership in the assessment, interpretation, and management of safety data for both investigational and marketed products. The successful candidate will play a key role in shaping product safety strategies, supporting clinical development, and driving regulatory safety activities throughout the product lifecycle.

The position offers the opportunity to lead complex safety evaluations and regulatory submissions in Japan, provide expert scientific judgment on emerging safety issues, and collaborate closely with local and global stakeholders to support informed benefit-risk decisions.

Key Responsibilities

Safety Evaluation & Risk Management Lead the assessment and interpretation of safety data for clinical development and marketed products. Conduct benefit-risk assessments and contribute to signal detection, evaluation, and management. Provide scientific recommendations on emerging safety concerns and Japan-specific safety strategies.

Support safety governance meetings and product safety decision-making. Regulatory Submissions & Compliance Lead or support safety-related activities for development programs and new drug applications. Prepare safety sections of regulatory submission dossiers and support PMDA interactions. Manage responses to regulatory inquiries and contribute to periodic safety reports, Risk Management Plans (RMPs), and reexamination submissions.

Support regulatory compliance and inspection readiness activities in Japan. Cross-Functional Collaboration Partner with local and global teams across Pharmacovigilance, Clinical Development, Regulatory Affairs, and other relevant functions. Provide expert safety input to clinical development plans and regulatory strategies.

Communicate complex safety findings and recommendations clearly to senior stakeholders. Influence safety-related decisions within a global, cross-functional environment.

Requirements

Requirements MD, Pharmacist, PhD, or another advanced degree in life sciences or a related discipline. Significant pharmacovigilance experience, ideally covering both clinical development and post-marketing safety. Strong knowledge of Japanese and global pharmacovigilance regulations and requirements. Expertise in safety reporting, signal management, benefit-risk assessment, and risk management.

Experience managing complex regulatory safety activities and working with global cross-functional teams. Native-level Japanese and fluent English communication skills. Strong scientific judgment, analytical capabilities, and stakeholder communication skills. Ideal Candidate Profile The ideal candidate is an experienced drug safety professional who combines strong scientific expertise with regulatory knowledge and strategic thinking.

They will be comfortable independently evaluating complex safety information, advising senior stakeholders, and leading Japan-specific safety activities that support critical development and regulatory milestones.