Japan Safety Operations Director (Pharmacovigilance)

Revolution Medicines, Inc.; United States; Híbrido; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Revolution Medicines, Inc. is seeking an Associate Director, Safety Operations, Japan to lead pharmacovigilance operations.

You will ensure timely, accurate safety information processing and reporting in collaboration with Global Patient Safety teams, CROs, and internal partners. Responsibilities include ICSR handling, data quality, aggregate reporting, PVAs, and Japan-specific pharmacovigilance activities in line with GVP/GPSP requirements and local procedures.

Formación

• Bachelor’s degree in healthcare or related field and strong pharmacovigilance experience.
• Minimum 7 years in pharmacovigilance/patient safety operations.
• Hands-on CRO/vendor management and regulatory compliance knowledge.
• Strong understanding of GVP/GPSP for clinical trials and post-marketing.
• Proficiency in developing pharmacovigilance procedures and workflows.

Responsabilidades

• Coordinate and review ICSR processing, follow-up, and expedited reporting.
• Review safety data quality, reconciliation, and issue resolution.
• Coordinate periodic and aggregate safety reports for Japan.
• Manage Safety Agreements and PVAs and data exchange timelines.
• Oversee Japan pharmacovigilance operations per GVP/GPSP and local procedures.
• Coordinate audits, CAPA, and regulatory inspections readiness.
• Monitor CRO/vendor performance and drive corrective actions.
• Develop Japan-specific pharmacovigilance procedures and workflows.
• Coordinate pharmacovigilance training for staff and partners.

Conocimientos

Pharmacovigilance

Safety reporting

CRO/vendor management

Regulatory compliance

Japanese proficiency

English proficiency

Educación

Bachelor’s degree in healthcare

Master’s degree or higher

Descripción del empleo

Revolution Medicines, Inc. is seeking an Associate Director, Safety Operations, Japan to lead pharmacovigilance operations.

You will ensure timely, accurate safety information processing and reporting in collaboration with Global Patient Safety teams, CROs, and internal partners. Responsibilities include ICSR handling, data quality, aggregate reporting, PVAs, and Japan-specific pharmacovigilance activities in line with GVP/GPSP requirements and local procedures.