PV担当官/ Pharmacovigilance Officer

A multinational pharmaceutical company is seeking a Pharmacovigilance Officer. The selected candidate will manage PV operations, risk management, and process improvement across the product lifecycle.

Responsibilities:

• Execute oversight of pharmacovigilance governance, including audit/inspection, CAPA management, QSD management, training, archiving, and outsourcing agreement management
• Implement and maintain local risk management activities throughout the product lifecycle in line with global and local standards
• Manage benefit/risk assessments, Japan Risk Management Plans (RMP), periodic safety reports, EPPV, and safety communications
• Standardise and continuously improve local PV processes to meet Japanese regulatory and global PV requirements
• Support colleagues through peer advice, capability building, and competency development in pharmacovigilance

Requirements:

• Bachelor’s degree or above
• More than 3 years of experience in pharmacovigilance activities
• Proven experience in pharmacovigilance or related fields such as CRO or pharmaceutical companies
• Proficient in MS Office Suite and IT systems
• Strong knowledge of medical terminology
• Fluent level Japanese; business level English (TOEIC 730+)

About the Company:

A multinational pharmaceutical organisation originating out of Europe that is responsible for the research and development of several widely recognised pharmaceutical products as well as products related to diagnostic imaging, women’s health and adhesives among others.

Keywords:

ファーマコビジランス, 医薬品安全性管理, リスク管理計画, 製薬業界, 安全性監視, コンプライアンス, PVガバナンス, メディカルインフォメーション, 求人, 外資系

Job Ref: BYBMJ9