Primary Responsibilities

• Awareness and understanding of relevant GVP modules.
• Perform medical review of non-serious & serious ICERS with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
• Experience of medical review of ICERS 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.
• Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
• Involve in process improvement activitie...