Clinical Safety Associate

San Francisco  ‐ Onsite
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Keywords

Description

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.
  • Ensures departmental workflow processes and timelines are followed.


Competencies Identified for Success:
  • Works effectively as a team member and promotes collaboration
  • Demonstrates initiative and accountability
  • Strong organizational skills, detail oriented, ability to adapt to change
  • Confident decision maker


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
Start date
12/2013
From
Real Staffing
Published at
27.11.2013
Project ID:
632995
Contract type
Freelance
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