Case Specialist- Pharmacovigilance (Clinical Trial)

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

Role:

• 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
• Related to particular activities carried out in their Business unit for specific clients

Education & Experience

• Doctor or pharmacist by training
• Minimum 4 years experience working for service providers performing QC of case
• Minimum 3 years of experience in processing Clinical Trial cases.
• SafetyEasy/ Argus database experience

Profile

• 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 English and French for business continuity