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Medical Reviewer with PV experience

Job Location: Prague

Regional Description: Czech Republic

Job Number: 00522012

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- Job description

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

In this position you would be responsible for medical review and assessment of Adverse Events 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 Medical Reviewer 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:

  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative and provide company comment in accordance with client requirements
  • Acquire and maintain current knowledge of product portfolio and safety profiles of for products across therapeutic areas
  • Identify, escalate and resolve case issues, co-ordinate with client therapeutic team/site for specific products or functional groups
  • Communicate and interact effectively
  • Follow up with sites regarding outstanding queries
  • Follow up on reconciliation of discrepancies
  • Perform other drug safety related activities as assigned

Requirements:

  • EU Medical Degree Required (e.g. MUDr., MBBS, M.D.)
  • Minimum 1-3 years of clinical experience
  • High degree of accuracy and attention to detail
  • Experience and skills in working on computers
  • European trained and certified physician with min 24 months clinical practice
  • Clinical experience in oncology/hematology would be an asset
  • Experience of ICSR management in a PV database (min 12 months), incl. triage, data processing, quality check, medical assessment and follow-ups
  • 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
  • Fluency in oral and written English

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