Responsibilities:
Responsible for the Quality control of vigilance cases

Medical evaluation of reports

Data entry of vigilance cases in ad hoc databases or in other formats agreed with the client

Follow-up request of vigilance cases by phone/mail

Pre-analysis of complex cases prior to data entry

Medical evaluation of files on:
Coding (according to applicable dictionary)
Causal relationship between the effects and the intake of suspect products (according to applicable method)
The expected/listed or unlisted nature of the events/effects/incidents
The seriousness of the events/effects/incidents and the case

Identification of submission requirements for each case

Validation of certain documents produced by the Data Manager/ Vigilance Associate / documentalist (phone call forms, etc)

Closing of vigilance files

Identification of requirements and applicable changes to set up ICSR/MLM filters

Analysis of inclusion / exclusion of EV/MHRA cases

Medical information in support of the medical information division

Answering phone calls that generate safety notifications

Review of medical information questions and quality complaints in order to identify safety information

Key Contact for specific customers (with the support of an Activity Manager or the Line Manager)

Writing/setting up quality documents in place:
Related to their activity
Related to particular activities carried out in their Business unit for specific clients

Education & Experience:
Doctor in Pharmacy/ Pharmacist by training

4-5 years of experience in a similar position

Skills:
Database experience preferred
Knowledge of current regulations
Process oriented
Rigorous and ability to work in a team
Use of Microsoft Office tools
Ability to multitask
Flexibility
Excellent communication skills