Case Specialist (IN)

• 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.
  

Ractice Level – Be Able To

• Establish causal relationship between the effects and
  

• Validate documentation.
• Ensure administrative processing of files
• Receive, record and acknowledge receipt of
  

• Maintaining internal and client files.
  

Mastery Level – Be Able To

• Follow-up of vigilance cases by phone/mail.
• Pre-analysis or analysis of complex cases before data
  

• Medical Review of certain cases.
  

Applicable Only For (Level II) - Advance Level

• Coding according to applicable dictionary
  

(MedDRA/IMDRF/Product/WHO Or Other).

• causal relationship between the effects and the
  

• the expected/listed or unlisted nature of the
  

• the seriousness of the events/effects/incidents.
• Pre-analysis of complex cases before data
  

• Identification of requirements in terms of
  

• Operations Project Owner to act as a technical