Amida Nchaw

Pharmacovigilance Scientist @P & N Vision Healthcare Services Inc

Worcester, MA, US

Signal detection, evaluation, and management - perform data analysis to evaluate safety signals and author analysis results for Safety Assessment Reports in collaboration with the GSO• Supports and reviews safety data in clinical trials, study protocols, statistical analysis plans, and other clinical study-related documents; reviews AEs/SAEs from clinical trials as needed; reviews the standard design of tables, figures, and listings for safety data from clinical studies; participate in the development of safety-related data collection forms for clinical studies and participates in study team meetings as requested or needed• Directs the planning, preparation, writing, and review of portions of aggregate reports• Organizes and directs liaison activities with affiliates and other internal Amgen partners regarding products• Authors various safety documents and health authority responses in collaboration with the GSO• Searches and reviews adverse event data, literature, and other safety-relevant data for signal detection• Prepares and presents Global Patient Safety’s recommendations on safety issues to the cross-functional decision-making body• Assists GSO in the development of risk management strategy and activities• Supports activities related to new drug applications and other regulatory findings