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Drug Safety Associate - Contract

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Marketing


Job Duties/Responsibilities:

* Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
* Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
* Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
* Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
* Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
* Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
* Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
* Participates on Study Management Teams (as applicable)
* Assists in the development of drug safety presentation for investigator meeting presentations.
* Assists in clinical trial reconciliation process (as applicable).
* Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.

Education, Experience, and Other Requirements:

* RN, BSN, PA, NP, MSN, MD, or PharmD required
* Minimum 2 years of clinical experience in a health care related field
* Computer proficiency and data entry experience preferred
* Excellent communication skills, both written and verbal
* Previous experience in Drug Safety (preferred)
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