CLINICAL SAFETY ASSOCIATE 1

Major Biotech with a location in S. San Francisco is seeking 2 Drug Safety Associates to join their team.

Description:
(CSA I) is a member of the Drug Safety Department and works within a project team structure. The CSA I is primarily responsible for reviewing adverse event (SAE) reports from an assigned project(s), clinical trials (CT) and/or post marketing spontaneous reports. The CSA I is responsible for completeness and clarity, defining and initiating follow-up through the appropriate channels, participating in the triage of these reports for regulatory reporting purposes.

Demonstrates basic knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
Demonstrates proficiency in case triage for project molecule and serve as a back-up for additional projects.
Identify proper case regulatory reporting requirement and seeks assistance when necessary.
Identifies and utilizes resources and support when available for adverse event triage and management.
Applies Good Clinical Practices document of phone, electronic, and/or fax correspondence regarding case follow-up per SOP. Competent and performs clinical triage per SOP. Identifies pertinent clinical information in Adverse Event reports and incorporates information in narrative.
REQUIREMENTS
Major Biotech with a location in S. San Francisco is seeking 2 Drug Safety Associates to join their team.

Requirements:
RN, BSN, PA, NP, MD, MSN, Pharm D. Clinical experience in a health care related field. Previous experience in Drug Safety required