Senior Safety Systems Lead, Japan – PV & Data Integrity

Revolution Medicines, Inc.; United States; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Revolution Medicines seeks an Associate Director, Safety Systems to lead safety systems operations for Japan, coordinating with Global Safety Systems and IT to ensure compliant use of global PV databases.

The role manages local administration, data quality, and regulatory requirements, aligning with GVP/GPSP and ensuring readiness for audits and inspections. Fluent English and native Japanese are required.

Qualifications

• Bachelor's degree in a scientific, technical, or related field is required.
• 7+ years' experience in pharmacovigilance systems, safety operations, or related domains.
• Experience supporting system changes, releases, and incidents.
• Knowledge of GVP/GPSP requirements for Japan is a plus.

Responsibilities

• Coordinate with Global Safety Systems to ensure effective use of safety databases in Japan.
• Manage Japan-specific system administration, user access, and workflows.
• Monitor data quality and system controls; investigate discrepancies.
• Coordinate Japan-specific requirements for system changes with stakeholders.
• Support validation, change control, and audit readiness for safety systems.

Skills

Pharmacovigilance systems

Safety operations

Collaboration & communication

English/Japanese proficiency

Education

Bachelor's degree in science/technical field

Tools

Safety One Argus

Empirica Signal

Spotfire

Oracle Analytics Server

Job description

Revolution Medicines seeks an Associate Director, Safety Systems to lead safety systems operations for Japan, coordinating with Global Safety Systems and IT to ensure compliant use of global PV databases.

The role manages local administration, data quality, and regulatory requirements, aligning with GVP/GPSP and ensuring readiness for audits and inspections. Fluent English and native Japanese are required.