Precision for Medicine - Drug Safety Specialist II - West Coast
Requirements
• Minimum 2 years safety experience • Health care professional • Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation • Working knowledge of MedDRA and WHODrug • Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations. • Preferred: • Nursing or pharmacy degree preferred • Clinical trial safety experience • Hands on experience with Argus • Industry experience in CRO or pharmaceutical company preferred • #LI-KH1 #LI-Remote
Responsibilities
• Essential functions of the job include but are not limited to: • Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems. • Participate in the assessment and set-up of a safety database to capture SAE data. • Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures. • QC of documents and safety reports. • Preparation and/or review of project-specific safety reporting plans and medical coding plans. • Preparation and/or review of safety training materials. • Provide safety training and oversight for consultants, contractors and/or staff. • Review and/or draft standard operating procedures and work instructions. • Assist clients and/or other departmental staff with safety-related reviews and other services.
Benefits
• Reasonable estimate of the current range • $75,600—$113,400 USD • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Apply in one click
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT