PV (MD)/ PV (MD)

A multinational pharmaceutical company is looking for a Medical Advisor – Patient Safety & Pharmacovigilance. The selected candidate will define and execute local PSPV strategies, provide benefit/risk expertise, and ensure compliance with global and local pharmacovigilance regulations.

Responsibilities:

• Define and implement local Patient Safety & Pharmacovigilance (PSPV) strategy for delegated assets and other products as needed
• Prepare and manage local Risk Management Plans (RMPs) in collaboration with global teams
• Monitor safety data and provide timely updates to relevant stakeholders
• Contribute to labelling documents, educational materials, and proper use guidelines
• Perform medical quality reviews of serious cases and manage health authority requests and potential safety issues
• Establish and maintain high-quality local PSPV systems aligned with global standards
• Conduct and contribute to internal/external PV training programs
• Support inspection readiness, audits, and manage CAPA activities for non-compliance
• Optimise local PSPV processes, including creation/revision of SOPs and local PV frameworks

Requirements:

• Medical Doctor (MD) with clinical experience
• More than 1 year of experience in the pharmaceutical industry within medical or clinical development
• Prior experience with local GVP/GPSP and global GVP regulations
• Experience in preparing periodic reports, RMPs, EPPV, and signal monitoring
• Proficient in project management, strategic thinking, crisis management, and mentoring others
• Native level Japanese; fluent level English

About the Company:

An international pharmaceutical firm that develops innovative healthcare solutions to improve patients’ lives. With several locations across the world, this company offers excellent career opportunities.

Keywords:

患者安全, ファーマコビジランス, 医療顧問, リスクマネジメント, 臨床開発, 医薬品, 規制対応, 医学知識, 求人, 外資系

Job Ref: 9BKW80