Country Safety Head

A global consumer health company is seeking a Country Safety Head Japan to oversee local pharmacovigilance activities and ensure compliance with applicable regulations and company procedures.

Responsibilities:

• Serve as the Local Nominated Person for pharmacovigilance and applicable cosmetovigilance or medical device vigilance activities
• Oversee local pharmacovigilance systems, resources, compliance, and day-to-day activities
• Manage and coach direct reports and oversee vendor resources as applicable
• Identify and escalate compliance issues and implement corrective and preventive actions
• Monitor local pharmacovigilance, cosmetovigilance, and medical device vigilance requirements
• Oversee adverse event reporting and responses to safety-related health authority queries
• Monitor regulatory changes and assess their impact on local safety processes
• Oversee safety reporting and submissions to local health authorities and relevant departments
• Ensure appropriate training on safety reporting responsibilities
• Provide technical and strategic input to local and global projects and workstreams
• Implement local procedures and assess the impact of global procedural changes
• Lead local health authority inspections and audits and support CAPA implementation
• Oversee local pharmacovigilance agreements and ensure appropriate implementation and training
• Ensure implementation of local business continuity plans

Requirements:

• Bachelor’s degree or above in a healthcare science field, preferably Medicine or Pharmacy
• 6-8 years of experience in pharmacovigilance or product vigilance
• Pharmaceutical industry experience including product vigilance responsibilities
• Experience managing direct reports and overseeing vendor resources
• Knowledge of product vigilance, drug development, and pharmacology principles
• Expert knowledge of applicable global, regional, and local procedural documents
• Knowledge of relevant IT safety systems
• Demonstrable knowledge of local requirements and global aspects of product safety
• Fluent level Japanese and English

About the Company:

A global consumer health company provides healthcare products and solutions to help people improve their everyday health and wellbeing. Its portfolio includes consumer health products across multiple categories and markets.

Keywords:

ファーマコビジランス, 医薬品安全性, 安全性管理, 製品安全性, 副作用報告, リスク管理, 規制対応, 医薬品業界, 安全性監査, 医療機関対応, 求人, 外資系

Job Ref: PELZJ6