Drug Safety Assistant

Principal Functional Responsibilities:

• Checking whether all the required training documents have been submitted by the users

• Checking the adequacy and relevance of the training documents for the access required

• Performing creation, modification or de-activation of the account in the corresponding regulatory tool, as applicable

• Updating the online tracking excel sheets for all the user accounts, as applicable

• Performing reconciliation and quality check for the access requests managed.

• Archiving the appropriate training documents in the shared drive and generic mail box, as applicable

• Informing the users that their accounts have been created, and contacting them via email for clarification, if required

• Identifying areas of concern within the team and raising issues with the Project Manager

• Involved in inspection readiness activities of the team, as required

QualificationsQualifications and Experience:

• Graduation/post-graduation degree in the Humanities or Sciences.

• Fluency in written and spoken English

• Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point)

• Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text

• Ability to evaluate data and draw conclusions independently

• Typing and transcription accuracy