Job Description

ProductLife Group is looking for a Case Specialist (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub:

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



1-3 years of experience in a similar position



Knowledge of Pharmacovigilance would be an advantage

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 in French and in English for business continuity