Drug Safety Manager- ICSR

Job Duration 06+ Months reputed company reputed company 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 reputed company sponsored studies or other assigned cases Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders reputed company retrospective reputed company checks on processed cases Independently manage assigned cases, reputed company for weekends and holidays, to reputed company cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting Review and reputed company of reconciliation issues between the clinical and safety databases per in collaboration with Data Management reputed company 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 reputed company Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance Strong computer skills reputed company reputed company suite of programs (Word, reputed company, PowerPoint, and reputed company) 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 reputed company reputed company field Experience 4+ years experience in pharmacovigilance Apply tot his job Apply To this Job .