Key Responsibilities

1. Responsible for the clinical safety monitoring and management plan, continued safety assessment, evaluation and risk management of Legend products in various stages of clinical development

2. Takes on activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimization; proposals for mitigation minimization measure; safety go-no go criteria for the clinical programme; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment

3. Provides medical input to ensure that risk-minimisation strategies are implemented appropriately in relevant documents such as ICF, IB, study protocol

4. Provides consistent communication of safety topics across all regulatory safety documents

5. Proactively evaluates the clinical implications of safety data from clinical studies, literature and other information sources in order to predict/ establish the safety profile of compounds in clinical development, including employing expert groups and methodologies, modelling and simulation to manage the risk to patients

Qualifications

1. Clinical Medical degree, professional designations/certifications/licenses

2. At least 3 years of clinical experience is required

3. Drug development experience and TA, drug safety knowledge is required

4. 2+ years industry experience relevant to PV or drug safety knowledge is preferred

5. Proactive and organized with solid habit of follow-up

6. Able to anticipate/ identify problems and takes appropriate action to correct and improve

7. High degree of accuracy with attention to details

8. Willing and able to learn quickly in a fast-paced environment

9. Excellent team player; express different viewpoints with colleagues in a proper and constructive manner

10.Excellent written and oral language skills in both Chinese Mandarin and English

上班地址：上海市