Specialist or Senior Specialist, Pharmacovigilance

Purpose:

This position is accountable for executing the day-to-day operations and compliance activities by leading

a team of PV operations to maintain high-functioning PV systems across assigned region remit. Reports

directly to Japan PV Operational Lead.

Responsibilities:

Metrics and Oversight of the Pharmacovigilance System

• Supports the provision of metrics that will ensure oversight of all aspects of the performance and

functioning of the PV system in compliance with local regulations and internal company

timelines/standards.



Quality Management System

• Develops and maintains local/regional procedures in line with corporate procedures and local

requirements.

• Performs the impact assessment of new/updated corporate policies, process, and procedures.

• Collaborate with Safety Science, along with Safety Control Manager, actively assists with the PV

Ex...