Sr. Safety Associate

Pay Range: $50-60/hr *depending on experience Job Scope: Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries. Key Responsibilities: * Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases * Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders * Perform retrospective quality checks on processed cases * Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting * Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management * Provide investigation details into late regulatory reporting of CT cases Essential Skills and Qualifications Required: * Knowledge of Global and local safety regulations * Excellent written and verbal communication skills * Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva * Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance * Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) * Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required Education and Experience Requirements for Job: Education : Bachelors degree in science or healthcare related field Experience : 4+ years experience in pharmacovigilance (No Value)