Primary function is the daily care and maintenance of the LFB USA rabbit colony used to produce pharmaceutical products.
Duties include basic animal husbandry, facility sanitization, animal restraint, feeding, milking, and record keeping.
Tasks must be carried out in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and accurately documented to maintain compliance with FDA mandated Good Manufacturing Practices (GMPs).
The Manager Drug Safety will be responsible for establishing and maintaining drug and biologic safety monitoring and reporting systems for products under development and marketed by LFB USA. The Drug Safety Manager will work independently with external vendors and clinical staff to ensure that all serious adverse events are properly recorded, evaluated, and reported to appropriate health authorities in a timely manner. This individual contributor will guide Clinical and Quality Assurance personnel to efficiently receive, record, evaluate and process adverse events, product complaints and medical inquiries for investigational and marketed products. Employee will generate various safety reports, in conjunction with corporate PV, to be used by DMCs, the Clinical Department and health authorities submissions.