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ProductLife Group
Case Specialist- Pharmacovigilance (Clinical Trial)ProductLife Group • ananthapur, India
Case Specialist- Pharmacovigilance (Clinical Trial)

Case Specialist- Pharmacovigilance (Clinical Trial)

ProductLife Group • ananthapur, India
1 day ago
Job description

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
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Case Specialist- Pharmacovigilance (Clinical Trial) • ananthapur, India

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