💼 About This Role

You'll lead safety management activities for Revolution Medicines' Japan entity and serve as the designated Safety Management Manager (Anseki). You'll ensure compliance with Japanese GVP/GPSP regulations and PMDA requirements, and collaborate with Marketing Supervisor General and Quality Assurance Manager. This role offers the opportunity to establish scalable safety governance and drive pharmacovigilance strategy for a late-stage oncology company.

🎯 What You'll Do

• Maintain compliance with PMDA, PV Agreements, and Japanese Risk Management Plan
• Lead design and maintenance of safety management system per GVP/GPSP
• Serve as primary safety contact for Japanese health authorities
• Establish safety-related SOPs and governance frameworks
• Oversee safety activities of global teams and external providers

📋 Requirements

• 10+ years pharmacovigilance/drug safety experience
• 3+ years safety management activities with regulatory negotiation
• Comprehensive knowledge of Japanese GVP/GPSP regulations
• Ability to communicate with Japanese health authorities in Japanese

✨ Nice to Have

• Experience as Safety Management Manager (Anseki)
• Experience interacting with PMDA
• Business-level English, native-level Japanese

🎁 Benefits & Perks

• 🏖️ Remote work within Japan
• 💰 Competitive compensation (estimated)
• 🧬 Impact on RAS-addicted cancers
• 🌍 Global multicultural environment

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Application review· 1-2 weeks
2. 2Hiring manager interview· 1 hour
3. 3Panel interviews· 2-3 hours

[email protected]