Drug Safety Associate

Works closely with the Drug Safety Management and/or assigned Project Lead to facilitate and meet client project deadlines. Provides support to other (Sr.) Drug Safety Associate staff to efficiently manage workload and ensuring timely reporting to Regulatory Authorities and to others as required. In addition to case management projects, this individual may also participate in the development of other EVERSANA-PV and client documents such as aggregate reports, safety management plans, standard operating procedures, and work instructions. Participation in and oversight of EVERSANA-PV client case processing activities. Collection of Adverse Events (AEs) from all sources, tracking of cases through case processing activities, and coordinating workflow activities to promote accurate reporting and efficient time management. Independently assess expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information. Independently code adverse events in MedDRA using clinical judgment and medications to WHODRUG. Perform a Quality Control check for completeness, accuracy, and consistency of information in the safety database and on regulatory reporting forms (e.g., MedWatch, CIOMS I). Independently create a draft narrative of the event(s) based on the description of the case provided by the reporter using a standard narrative construction guide.