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Drug Safety Associate

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support


* Processing and assessment of SAEs
* MedDRA coding of SAEs and AEs as reported in source documents of SAE reports
* Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician
* Generating reports as required
* Review of study protocols, case report forms, Investigator Brochures and participation on IND Annual reports with the support of the Drug Safety Physician
* Development, review and update of drug safety forms and templates
* Training a new safety staff on Argus and case processing
* Collaborating with other departments to ensure appropriate collection and handling of safety data


* BS/BA degree in related discipline
* MS/MA degree in related discipline
* PhD in related discipline
* BS or MS in nursing, Pharmacy or other clinical degree, preferably in health science field with a minimum of five years of clinical experience
* Minimum of three years of experience with a Drug Safety database - Argus preffered
* Typically a minimum of 5 years of related experience and/or combination of experience
* Experience in Biotech/Pharmaceutical industry and/or in oncolgy preferred
* Trained and proficient in Argus
To find out more about Real please visit www.realstaffing.com


  • Einsatzort:

    San Francisco, California, Vereinigte Staaten

  • Projektbeginn:


  • Projektdauer:

    Keine Angabe

  • Vertragsart:


  • Berufserfahrung:

    Keine Angabe

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Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland