Education:Doctor
Release date:
Salary:Negotiable
Work experience :Unlimited experience
City:Xiamen, Fujian Province
Categories: Other professional technical services, Others
First-level areas:Others
First-level areas:Other professional technical services
Source:Social Recruitment
Job description :
Duty.
1. Proactively provide medical professional leadership to improve the quality of clinical trials. Review/write documents submitted to NMPA, including but not limited to. clinical project evaluation report, protocol, CSR, CTD documents, and other documents required by the project team.
2. Provide scientific and medical guidance for clinical trials.
3. Prepare a medical monitoring plan for the research project.
4. Provide project related medical training for clinical trial teams.
5. Guide the medical coding work of the DM team and review the results of medical coding for adverse events, medical history, concomitant medications, etc.
6. Responsible for conducting medical reviews of serious and non serious adverse events in spontaneous reports and clinical trial reports, as well as medical reviews of medical literature supporting clients in drug safety activities during post marketing supervision.
7. Medical review of designated cases, including. review narrative, coding (e.g. MedDRA), accuracy assessment (severity, anticipation, knowledge, association), adverse events (severe and non severe), and adverse drug reactions (severe and non severe). Write medical questions and similar event analyses, provide causal relationship assessments and corporate opinions for individual cases.
8. Participate in research project related meetings and provide medical advice
Qualifications for the position.
1. Major in neurology or psychiatry, with a doctoral degree or above; You can apply for a homestead in the later stage of the residency;
2. Familiar with clinical trial procedures and relevant laws and regulations at home and abroad;
3. Having a solid foundation in medical knowledge and proficient skills in literature review, organization, and analysis.
4. Have a clinical medical background and relevant work experience in medical monitoring and auditing;
Please send your CV or resume as an attachment to the following email address:
mailto: rbhr@hrcenter.co.uk
With the subject line formatted as: ‘Name + Position + Company Name + Location’.