Director/Associate Director, Safety

About This Role

This role involves leading all pharmacovigilance (PV) and safety operations for pre-approval clinical development programs and post-marketed products as an Associate Director or Director of Global Safety Operations. The position supports safety activities in Japan and globally, ensuring compliance with regulatory requirements, internal procedures, and inspection readiness.

Responsibilities

• Oversee safety-related operations, deliverables, and documentation throughout the product lifecycle
• Maintain and continuously improve pharmacovigilance systems and processes, and support Marketing Authorization Holder (MAH) responsibilities as needed
• Execute and maintain operations based on Japan's GVP/GPSP requirements and other applicable laws and guidelines
• Lead or support the creation, review, and maintenance of RMPs, PMS plans and reports, aggregate safety reports, periodic reports, SOPs, and safety reporting plans
• Support safety activities, safety reporting compliance, and cross-functional studies for global clinical development programs
• Oversee post-marketing pharmacovigilance obligations and commitments to regulatory authorities
• Manage the quality, compliance, performance, and timeliness of vendors and CROs entrusted with safety operations
• Maintain and strengthen inspection readiness through audits, inspections, CAPA, deviation management, and quality improvement activities
• Coordinate with Regulatory Affairs, Clinical Development, Data Management, Quality Assurance, Medical Affairs, and other departments
• Develop, harmonize, and improve global safety processes, procedures, systems, and training programs
• Provide leadership, guidance, and mentoring to global and domestic teams

Requirements

• Bachelor's degree or higher in a life science-related field
• 7+ years of experience in pharmacovigilance, drug safety, clinical safety, or safety operations within the pharmaceutical, biotechnology, or medical device industry
• Experience supporting both clinical development and post-marketing pharmacovigilance
• Advanced knowledge of pharmacovigilance-related laws, guidelines, and practices (e.g., PMDA, ICH, FDA, EMA)
• Experience in creating and maintaining SOPs, RMPs, PMS documents, and aggregate reports
• Experience in vendor management, quality oversight, and inspection readiness
• Experience in ICSR processing, safety reporting, safety databases, and pharmacovigilance operations
• Leadership and project management experience in global, cross-functional, and multicultural environments
• Business-level English proficiency (reading, writing, and conversation)

Nice to have:

• Medical professional qualification (pharmacist, physician, nurse, etc.)