Job Description
Responsible for the following Case processing tasks as a member of the clinical information or post-marketing drug or medical device safety information management project:Receipt of information on adverse events, entry in databaseCreation of case description (Japanese, English)Primary evaluation of the necessity of reporting a defect to PMDACreation of adverse drug reportQC check
Responsibilities + Skills
Education
Provide accurate individual case reports for submission to regulatory authorities, sponsors and and participating clinical trial investigators in compliance with regulatory requirements and time frames for reporting.
Experience
