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Drug Safety Case Processor with PV experience

Job Location: Prague

Regional Description: Czech Republic

Job Number: 00521952

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- 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.

Responsibilities:

  • 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

Requirements:

  • European trained and certified Health Care Professional (pharmacist, nurse or dentist)
  • Experience of ICSR management in a PV database (min 12 months), incl. triage, data processing and quality check
  • Experience in MedDRA coding execution ( LLT, PT, SOC, SMQs)
  • GVP modules - Especially module VI (Management and reporting of adverse reactions to medicinal products)
  • An overview of PV in post-marketing & clinical trials settings (assessment of Listedeness/expectedness against of IB/CCDS)
  • Experience in oncology is desirable
  • Fluency in oral and written English
  • High degree of accuracy and attention to detail in translation

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