- The collection and documentation of each adverse event transmitted by the local Consumer Advisory Department or any other source
The medical review of each adverse event
The medical expertise for the local regulatory and legal dossiers
The seriousness assessment of each adverse event
Interfacing with the local Consumer Advisory Department on Post Marketing Safety requirements (trainings of Consumer Advisory Department employees)
Training of local employees on local vigilance activities and processes
Being involved in the scientific communications with health professionals (e.g. dermatologists) on the medical analysis of adverse events, product safety profile, etc.
Interfacing with regulatory authorities on Post Marketing Surveillance issues
The reporting of adverse events to China regulatory authorities, being compliant with the regulations
Being involved in the protocol design of the clinical studies, and the evaluation of adverse events reported during clinical studies
The global post marketing safety analysis on specific formulas, and being involved in the risk management
- Education background
- Required professional experience.
- Mandatory technical skills and Nice to have technical skills
- Fluent in English
- Majoring in clinical medicine
2-5 years’ working experience in materiovigilance or pharmacovigilance is preferred
Strong interpersonal skills and team work spirit with the ability to work effectively in a matrix-type organization
Good communication skills and ability to manage difficulties
Be flexible with the ability to manage multiple projects simultaneously with minimal guidance
Excellent oral and written communication skills in both Chinese and E
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