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Medical Safety Analyst

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Medical Safety Analyst állás Budapest, Közép-Magyarországi Régió Magyarország
tata

Medical Safety Analyst

Introduction

 

You will drive reports of drug side-effects from post-marketed or clinical study source to the safety database. Handle non-serious and serious cases according to regulatory requirements, process instructions and standard operational procedures. Resolve queries related to pharmacovigilance activities and individual case reports.

 

Function

 

Processing of adverse event reports

  • Enter complete information from the safety report
  • Perform appropriate clinical assessment (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements.
  •  Code reported adverse events with Meddra
  • Seek medical advice
  • Raise queries if needed
  • Proper triage of the case
  • Archive the source document
  • Complete data entry according to the process instructions
  • Perform all activities within the required timeframes

Requirements

Required:

  • Bachelor’s Degree in Life Sciences or Healthcare degree.
  • Advanced competency with medical and therapeutic terminology

Advantages:

  • Prior Experience in pharmacovigilance
  • A minimum of 2 years' experience in Pharmaceutical industry or in a clinical setting (including experience in hospitals, nursing homes, or clinics) is preferred;
  • Experience in researching information utilizing available resources including publications and the World Wide Web;

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