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Drug Safety Case Processor

Job Location: Prague

Job Number: 00470186


- Job description

Join an interesting project supporting an international pharmaceutical company by providing data processing in the safety database for received source documents of cases collected during safety monitoring of drugs and compounds.

This includes triage, data entry, coding and narrative writing of individual case safety reports within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard operating procedures and global regulatory requirements as documented in Customer’s SOPs

Additionally, the Case Processor ensures integrity and consistency of data against source document by performing QC and appropriate correction of all processed cases in appropriate timelines as per standard operation procedures.


  • Case intake, duplicate check and registration of the case into the safety database
  • Case validation and triage
  • Data entry of Individual case safety reports into the safety database
  • Full data entry including medical coding and safety narrative
  • Responsible for medical coding (e.g. MedDRA, Company Product Dictionary, DRL code)
  • Review data entered in safety database for completeness and accuracy
  • Conduct Review and assessment of individual case safety reports obtained and route cases to approval via workflow
  • Perform causality assessment
  • Communicate and interact effectively
  • Follow up with sites regarding outstanding queries
  • Follow up on reconciliation of discrepancies
  • Handling case deletion if applicable
  • Perform other drug safety related activities as assigned
  • Fluency in English
  • Pharmacist, nurse or dentist (bachelor degree from EU university in any of these areas is essential)
  • PV experience is preferred
  • High degree of accuracy and attention to detail in translation
  • Knowledge of medical terminology is preferred
  • Familiar with regulatory & Pharmacovigilance guidelines & Pharmacovigilance terminology
  • Experience and skills in working on computers (word processing, spreadsheets, safety database tools)
  • Good typing speed
  • Proficiency in prioritizing assignments and ability to adapt to rapidly changing priorities
  • Good knowledge of business regulations and standards an advantage
  • Good written, verbal and organizational skills

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