Description
We are looking for a Data Officer to have responsibility for allocated tasks within the pharmacovigilance activities delivered by the platform.
- Data entry of vigilance cases in the relevant databases
- Preparation of initial email (in the context of follow up request), requests for clarification
- Submission of cases to the competent authorities
- Carrying out specific queries in the databases in order to draft reports
- Monitoring and downloading ICSRs in the national databases (Eudravigilance, MHRA portal)
- Monitoring a generic mailbox and support in the registration and the initial triage in the database
- Quality control of vigilance cases
- Recordings/updates on XEVMPD
- Drafting/updating of technical agreements /safety management plan /client template
- Drafting/updating of SOPs/WPDs/Trainings others documents directly related to their activity
- Participation in the implementation/maintenance/improvement of processes