Case Specialist (Pharmacovigilance) 345

ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the pharmacovigilance 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:

1. Coding (according to applicable dictionary)
2. Causal relationship between the effects and the intake of suspect products (according to applicable method)
3. The expected/listed or unlisted nature of the events/effects/incidents
4. 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:

1. Related to their activity
2. Related to particular activities carried out in their Business unit for specific client

Education & Experience:

• Doctor in pharmacy/ pharmacist by training
• 1-3 years of experience in a similar position
• Knowledge of Pharmacovigilance would be an advantage