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Medical Reviewer with English

Job Location: Prague

Job Number: 00470162

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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
  • Medical Degree from EU university required (e.g. MUDr., MBBS, M.D.)
  • Minimum 1 year of clinical experience
  • Fluency in English
  • Very good competency with medical and therapeutic terminologies
  • Ability to read and understand medical source documents and to summarize them in a well-written narrative
  • Familiar with regulatory & Pharmacovigilance guidelines & Pharmacovigilance terminology
  • High level of accuracy and attention to detail
  • Experience and skills in working on computers (word processing, spreadsheets, safety database tools)
  • 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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