Drug development and regulatory submission are increasingly being carried out on a global scale, and safety-related problems must now be evaluated comprehensively, without sticking to concepts such as whether they are considered to be pre- or post-marketing.

Capabilities

• Primary evaluation of overseas information, and translation into Japanese, using CIOMS I / MedWatch forms.
• Entering safety information into the safety database for Japanese clinical-trial and post-marketing, followed by primary evaluation, and translation into English.
• Primary screening and primary evaluation of references and academic conference information
• Tasks relating to English translation (CIOMS I / MedWatch preparation)
• Support for instruction tasks to CRA
• Draft various safety information reports from clinical trials and post-marketing studies: side effects and infection case reports, research reports, action reports, adverse event case reports, etc.
• Draft various periodic safety information reports from clinical trials and post-marketing studies: Periodic reports for unknown and/or non-serious events, periodic safety reports, safety sections of repeated-review applications, annual clinical trial safety reports, periodic benefit/risk evaluation reports (PBRER), periodic safety update reports (PSUR), development safety update reports (DSUR), pharmaceutical risk management plans (RMP), etc.
• Primary evaluation of periodic infection reports, and preparation of periodic infection report drafts.
• Consulting overall safety information management tasks, and other related general tasks
• Tasks relating to preparation of various report types: Preparation of draft documents for the in-house Safety Evaluation Committee, and preparation of draft reports for overseas headquarters, and overseas affiliated companies