Drug Safety Specialist II - West Coast

Responsibilities

• Development of safety management plan
• Case management of serious adverse events (SAEs, SUSARS) from intake to regulatory reporting
• Providing safety expertise as requested by team members, clients, and study site personnel
• Interfacing with sponsors, vendors, and internal team members to assist in the design and implementation of safety collection tools, processes, and reporting systems
• Assessment and setup of a safety database to capture SAE data
• Data entry, medical coding, expectedness assessment, and composition of narratives and analyses of ICSRs, following applicable regulations and company policies and procedures
• Quality control 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
• Providing safety training and oversight for consultants, contractors, and/or staff
• Review and/or drafting of standard operating procedures and work instructions
• Aid clients and/or other departmental staff with safety-related reviews and other services

Qualifications

• Bachelor's degree (BA/BS) in relevant field
• Minimum 2 years of safety experience
• Healthcare professional experience
• Experience with global safety databases, 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