MISSION:

The Case Specialist’s job is to guarantee the optimised management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files. He/she is the guarantor of the proper handling of a case, both from a regulatory and medical point of view, and in this respect masters the regulations in force. He/she must be able to validate all tasks related to the exploitation of cases, from their collection to their submission. In addition, he/she contributes to the smooth running of his/her Line Of Business.

 

Main activities and technical skills:

VIGILANCE CASES:
  • Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields:
  • Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other).
  • Seriousness of the events/effects/incidents .
  • Expectedness/listedness. – Data entry of vigilance cases in ad hoc databases or in formats defined with the client.
  • Follow-up request of vigilance cases by phone/mail
  • Suggesting queries to complete the case.
  • Confirm or support Data Officers submission requirements.
  • Validation of documents within the Safety and Vigilance platform.
  • Analysis of inclusion/exclusion for cases received from EV or MHRA ICSR download.
  • Reconciliation activities.
MEDICAL INFORMATION:
  • In support of the medical information line of Business
  • Taking phone calls reporting vigilance notifications.
CUSTOMER/PROCESS MONITORING:
  • Participation in the operational implementation of new clients.
  • Key contact with clients (with the support of a senior member of staff or the division manager).
  • Drafting/updating of technical agreements /safety management plan / client template (for a trial for example)
  • Drafting/updating of procedures/ operating methods or others directly related to its activity
  • Participation in the implementation/ maintenance/ improvement of processes
Additional Activities:
  • Participation in the coordination of Case Management by relaying to the coordinator if necessary.
  • Support for the coordination of activities (including planning and monitoring) ensuring effective communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines.

 

Required Education:

BPharm / MPharm

 

Required Experience:

4-5 years

 

Required Technical Skills:

Well versed with MS Office, Safety Databasea

 

Additional Skills & Experience:

Presentation skills, Communication Skills, Should be well versed with pharmacovigilance basics, case processing and associated conventions, thorough knowledge of GVP modules, ICH guidelines, regulatory requirements, MedDRA coding, well versed with safety databases, solution oriented.

Case Specialist – VAF 365

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