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Job #02919

About our client Our client is a publicly traded biopharmaceutical company that is dedicated to the development and commercialization of drug delivery therapies. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate. Position Location Drug Safety Specialist Miami, Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in development and review of content for conventions and SOPs 2) Perform single case review for medical content and accuracy (as assigned) 3) Confirm reportability 4) Consult source documents (as needed) 5) Initiate additional follow-up or queries 6) Enter corrections in to the system (as required) 7) Communicate potential signals to Drug Safety Physician (DSP) 8) Assist with surveillance activities, including review of case series and frequency reports 9) Provide education, training and feedback to DSP resources 10) Represent Drug Safety in internal and external meetings 11) Participate in recruiting and coaching DSP resources 12) Perform complete data entry of all adverse event (AE) reports within the scope of Operations’ responsibility 13) Demonstrate proficiency in writing AE summary narratives for all cases within the scope of Operations’ responsibility 14) Review and evaluate AE case information to determine required action, based on and following internal policies and procedures 15) Follow departmental AE workflow procedures 16) Assist with special projects (as assigned by and under the direction of the Drug Safety Operations Supervisor and/or Clinical Drug Safety personnel) Requirements 1) RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or a related degree (or Associate degree in a relevant field with commensurate drug safety experience) 2) 3 – 5 years of experience in a pharmaceutical company or clinical environment 3) 2 – 3 years of drug safety experience 4) Experience in working in a high-volume environment 5) Expertise in Argus and basic MS Office applications 6) Working knowledge of eDocs and understanding of RADocs and GRASP 7) In-depth understanding of FDA and international regulations 8) Knowledge of scientific terms, medical terminology and MedDRA 9) Excellent writing skills 10) Ability to apply clinical or drug safety experience in AE assessment 11) Ability to manage assigned workload independently and effectively