offre-emploi


Case Specialist (Chargé de vigilance) > Lyon > Joboolo FR :


Société : ProductLife Group
Lieu : Lyon 69000

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




Specific activities and 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

  • To perform the QC for post-marketing cases

  • To provide specialised and dedicated pharmacovigilance support to the team specifically with the review, assessment and querying of safety reports.

  • To perform medical review of post marketing cases as assigned.



Required education:


Pharmacist or Life Science Degree



Required experience :



  • Min 2 years experience in PV case processing

  • PV database experience- Safety Easy

  • Knowledge of GCP/GVP

  • Deep experience in PV principles, adverse event reporting, causality assessment

  • Experience of communicating directly with clients



Required Languages:



  • French (Full professional)

  • English (Full professional)



Required technical skills:



  • Microsoft Office

  • Teamwork

  • Attention to detail

  • Flexibility

  • Process Orientated

  • Organization


ProductLife Group
Lyon 69000
Autre(s)
VIE
0 mois





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