Rania Hakimi Email & Phone Number

- Oversee the proximity management of a dedicated team, ensuring effective communication and workflow.- Act as the communication link between the activity manager and team members, facilitating the flow of information.- Lead the implementation of new clients processes within the team, ensuring smooth transitions.- Monitor team workload, providing regular reports to activity managers and the coordinator.- Support team members’ professional growth through training plans… Show more - Oversee the proximity management of a dedicated team, ensuring effective communication and workflow.- Act as the communication link between the activity manager and team members, facilitating the flow of information.- Lead the implementation of new clients processes within the team, ensuring smooth transitions.- Monitor team workload, providing regular reports to activity managers and the coordinator.- Support team members’ professional growth through training plans, promotions, and skill improvement in alignment with organizational needs.- Analyze results from quality controls, identifying areas for improvement and proposing actions in consultation with team leaders.- Drive and implement process enhancements and tools to optimize the activities of the business unit and division. Show less

- Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other), Seriousness of the events/effects/incidents, Expectedness/listedness.- Confirm or support Data Officers submission requirements.- Monthly analysis of quality control from the client and monitoring of KPIs.- Training of the team according to customer conventions/SOPs/EMA guidelines.- Participation in the preparation… Show more - Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other), Seriousness of the events/effects/incidents, Expectedness/listedness.- Confirm or support Data Officers submission requirements.- Monthly analysis of quality control from the client and monitoring of KPIs.- Training of the team according to customer conventions/SOPs/EMA guidelines.- Participation in the preparation of PV audits/inspections.- NC and CAPA support for case processing. Show less

- Data entry of vigilance cases into the relevant databases (Argus Safety).- Submission and transmission of files to competent authorities and partners.- Inclusion/exclusion analysis of cases from Eudravigilance.- Carrying out specific queries in the databases in order to draft reports.

Mégrine, Ben Arous, Tunisia

Tunisie