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