クリニカルセーフティアソシエイトディレクター/ Clinical Safety Associate Director

A global clinical research organisation is seeking an Associate Director, Clinical Safety. The selected candidate will oversee clinical safety operations, provide expert pharmacovigilance guidance, manage stakeholder relationships, and drive safety-related process improvements.

Responsibilities:

• Oversee clinical safety case management and aggregate reporting at the programme level
• Maintain relationships with clients and internal stakeholders by providing expert safety knowledge
• Provide safety review of clinical study documents, including protocols, study reports, and marketing application components
• Identify and manage process improvements, SOP updates, and training initiatives
• Act as an internal and external advisor on safety-related matters
• Manage teams and support employee development within the clinical safety function
• Oversee departmental hiring, training, management, and evaluation of Clinical Safety employees and support personnel
• Develop safety plans, Standard Operating Procedures, guidelines, and narratives

Requirements:

• Bachelor’s degree or equivalent
• 5- 8 years of experience in clinical safety within a CRO environment
• Experience in a leadership role within clinical safety or pharmacovigilance
• Experience managing clinical safety operations, SOP development, training, and team management
• Strong understanding of pharmacovigilance processes and clinical safety frameworks
• Bilingual level Japanese and English

About the Company:

A global full-service clinical research organisation supports biotechnology and pharmaceutical companies in accelerating drug development through end-to-end clinical trial services across all phases of research. It is recognised for its strong scientific expertise, data-driven approach, and regulatory excellence, offering career opportunities in clinical operations, data management, biostatistics, pharmacovigilance, and regulatory affairs within the fast-growing CRO and clinical research jobs sector.

Keywords:

臨床安全, ファーマコビジランス, 医薬品安全性, 臨床試験, SOP管理, 規制対応, 医薬品開発, リーダーシップ, CRO, バイリンガル, 求人, 外資系

Job Ref: J3QJO9