Drug Safety Specialist
Hyderabad, India Job ID R0000027838 Category Medical SciencesAbout this Role
Job Description: -
• The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
• Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable.
• Responsible for ICSR compliance and quality related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable
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