Location Tokyo, Kanto
Languages Japanese > Native
English > Business Level
Job number JO-200827-224864

Company overview

A global pharmaceutical company

Job description

Ensure the timely collection, assessment, coding and processing of serious adverse event reports related to the clinical or marketed drug products within the established time frames and in compliance with global regulatory requirements. In this role, the individual will serve as primary oversight for receipt and accurate entry of serious adverse events into the Safety Database.
1. Manage local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
2. Manage case processing activities, and review processed cases to verify accuracy, consistency and compliance with process requirements
3. Participate in compliance activities

Requirements

• Bachelor’s degree in science or health care related field.
• Ideally, at least 7 years’ experience in the pharmaceutical industry with at least 5 years in a drug safety/pharmacovigilance role.
• Experience working with drug safety databases and managing and tracking of
serious adverse event reports

Additional information

JO-200827-224864

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