Pharmacovigilance - ICSR Case Processing

Job Title: Pharmacovigilance - ICSR Case Processing Location: Cambridge, MA 02142/Hybrid- 2 days Office Duration: 12 Months+ (Possible Extension) Pay Range - $50 - $60/hr. on w2 Job Product Responsible for case processing and/or QC of clinical trial ICSRs and post market case processing from sanctioned countries. Key Responsibilities: • Triage, Intake, case entry and QC of ICSRs originating from *** 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 (Clinical Trials) 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 : Bachelor's degree in science or healthcare related field Experience : 4+ years' experience in pharmacovigilance Apply tot his job Apply To this Job