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 ad hoc databases or in formats defined with the client
Preparation of initial email (in the context of follow up request), requests for clarification and
acknowledgements for the investigation of vigilance cases
Submission of cases to the competent authorities on the instructions of a case specialist
Carrying out specific queries in the databases in order to draft reports
Setting up ICSR and MLM filters on the instructions of a case specialist
Carrying out of EV ICSR download and MLM search
Carrying out recordings/updates on XEVMPD
Carrying out of MHRA ICSR downloads
All the missions of the vigilance associate position
Extraction of data for the calculation of quality indicators
Preparation of activity reports for clients and activity monitoring for the calculation of quality / performance indicators
Participation in the coordination of the Line of Business Case Management by relaying to the coordinator if necessary
Planning and monitoring of the activities of the Line of Business Case Management, relaying them to the coordinator if necessary
Carrying out periodic reports and activity monitoring for transmission to clients
Participation in audits to present the activity.
Manage the processes related to the division’s activities and to ensure their proper implementation within the division
Education & Experience
Bachelor’s degree in science related field
Fresher or 1 year of PV experience
Skills
Excellent communication skills in English
Process oriented
Enjoys working with documentation
Works well within a team
Knowledge of medical terminology
Organized
Responsible
Good computer skills