Drug Safety Associate-武汉

Assist in development of project specific safety procedures, workflows and templates

Assist in project specific safety database setup and user acceptance testing

Assistance in development of Expedited Reporting Procedures

Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor

Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)

Submission of safety reports to investigators via ISIS (International Safety Information System)

Assist with measuring investigative site performance in conducting required tasks in ISIS

Tracking and filing of submission cases as required

Assist with unblinding of SUSARs, as required

Support collection and review of metrics for measuring reporting compliance

Assist with additional Drug Safety Specialist and/or Medical Operations Leader (MOL) activities as required

Inform Line Manager (LM)/Team Manager, Medical Operations Leader (MOL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects

Participate in client and investigator meetings as required

Attend internal, drug safety and project specific training sessions

Preparation for, participation in, and follow up on audits and inspections

Delegate work as appropriate to Drug Safety Assistants QualificationsSkills:

•Analytical and problem solving skills

•Able to perform database/literature searches

•Excellent interpersonal skills

•Excellent verbal / written communication skills

•Excellent organizational and prioritization skills

•Ability to work collaboratively and effectively in a team environment

•Client focused approach to work

•Experience with computer applications

Knowledge and Experience:

•Related experience gained in a healthcare environment is an advantage