Signal Detection/Drug Safety Associate II Contract Job Title: Signal Detection/Drug Safety Associate II Responsibilities The contractor resource will be the key contact on the SM Simplification Project work streams. Bring industry expertise to support the Simplification Project and will provide strategic feedback to GSS and project team. Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool. Assess currently utilized quality documents and develop/modify business processes as needed. Develop training materials and provide training. Develop and implement a consistent process to produce KPIs. Work closely with PM to ensure that timelines are met. Coordinate and lead SMC meetings. Qualifications Experienced in signal detection tools and processes Skilled in implementing new business processes and technology solutions for signal detection in clinical development Experienced in LEAN methodology Working knowledge of regulations related to signal detection (GVP Module IX) Proven expertise working with FAERS and WHO-Vigibase data Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process At least 5+ years of pharmacovigilance experience, especially in signal detection and management Strong consulting experience Excellent Excel/WP/PowerPoint and technical writing skills Clinical experience a plus Education Education: #J-18808-Ljbffr Integrated Resources Inc.
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SUMMARY/JOB PURPOSEThis role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs). This role provides support for all major tasks and oversight of outsourced vendors, related...