Drug Safety Manager- ICSR

Job Duration: 06+ Months Job 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 deliver 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 : Bachelor’s degree in science or reputed company reputed company field • Experience : 4+ years experience in pharmacovigilance Apply tot his job Apply To this Job