Drug Safety Specialist

San Diego  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Responsibilities:
  • Manage all aspects of clinical drug safety, including SAE process
  • Manage and ensure compliant safety reporting in accordance with international reporting regulations, and SOP's
  • Cultivate and maintain a synergistic relationship with all personnel
  • Participate in monitoring, review and analysis of safety data


Requirements
  • RN, BSN with clinical , pharma experience and experience in clinical drug safety in biopharma or pharma environment
  • Detailed understanding of GCP, FDA regulatory reporting requirements and ICH guidelines
  • Experience with clinical trial databases, Documentum and MedDRA preferred
  • Able to work under time constraints to meet reporting deadlines


To find out more about Real please visit www.realstaffing.com
Start date
09/2013
From
Real Staffing
Published at
17.09.2013
Project ID:
599607
Contract type
Freelance
To apply to this project you must log in.
Register