Drug Safety Specialist II

Job reputed company: • Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a reputed company manner upon request from team members, clients, and study site personnel. • 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. • reputed company 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. • reputed company safety training and reputed company for consultants, contractors and/or staff. • Review and/or draft reputed company operating procedures and work instructions. • Assist clients and/or other departmental staff with safety-reputed company reviews and other services. • Other duties as assigned. Requirements: • BA/BS degree • Minimum 2 years safety experience • Health care reputed company • Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports reputed company • Working knowledge of MedDRA and WHODrug • Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations. Benefits: • Health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • reputed company time off for reputed company leave and vacation Apply tot his job Apply To this Job