1. Review of the experimental protocol: Participate in the formulation and review of pathology in the preclinical toxicology experimental protocol of new drugs, provide opinions and suggestions from a professional perspective, and ensure that the methods used in the pathological part of the experimental protocol are scientific and correct. Provide professional advice as much as possible in other areas of the experimental protocol;
2. Anatomy supervision: Responsible for the quality of the anatomy, ensure that the anatomy process meets the requirements of the experimental program and follow the relevant experimental operating procedures, and report any special emergencies in the anatomy process to the person in charge of the experimental subject and make corresponding processing and records;
3. Histological diagnosis: record and interpret the pathological changes in the readings. At the same time, it is necessary to ensure that the organs required by the test plan have been prepared and the consistency of the sampling site and the consistency of staining; the standard of diagnostic terms used is unified, and the degree of diagnostic grading is consistent;
4. Pathology report writing: After the reading, the pathology subject leader is responsible for writing the pathology report according to the corresponding SOPs or completing the pathology part of the general report, and describing the changes related to drug treatment and other important findings in the report, and giving corresponding Possible explanations and connections to other data, such as clinical data, are stated in the discussion. Also ensure that the report is accurate and fully reflects the original results;
5. Quality control: No matter what method is used for recording, such as electronic data acquisition system, paper documents, etc., it is necessary to ensure the integrity and accuracy of experimental data and that the experimental protocol and corresponding SOPs in the experimental process are followed. Perform quality checks after forms and reports are generated and before filing and QA review;
During the whole experiment, maintain good communication with the person in charge of the experiment, and report any situation in the experiment to him in time. Any comments and questions from the test quality assurance department will be answered and resolved as soon as possible.
1. Master's degree or above in pathology, comparative tissue and anatomy of experimental animals, hematology, physiology and medicine, biology, veterinary medicine, experimental design, statistical analysis, etc.;
2. Deeply understand the principles and requirements of GLP in toxic pathology, and possess the core skills and knowledge required for the position;
3. Familiar with pathological auxiliary diagnosis techniques and methods, such as light microscopy, electron microscopy, special staining and immunohistochemistry;
4. Familiar with clinical detection indicators and the biological significance of each indicator, cytology, hematology and their possible connections with some pathological phenomena;
5. Basic familiarity with laser confocal, fluorescence microscopy, morphometric techniques and some modern molecular biology techniques, such as in situ hybridization, laser capture microdissection;
6. Understand the basic knowledge of pharmacokinetics, toxicokinetics and genomics, proteomics, metabolomics, etc.
Familiar with the basic principles and requirements of animal welfare.