Senior Associate, Medical Review Physician

Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.…