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Drug Safety and Pharmacovigilance (AD to ED level)





The core responsibilities of Drug Safety Physician is to build-up a PV team and a PV system to support company’s clinical projects and to fulfil MAH PV requirements. The specific responsibilities include those listed below:

• Take the leadership role in clinical project by providing drug safety oversight;

• Review and provision of medical opinion on various reports regarding drug safety prepared within the legal framework of pharmacovigilance;

• Answer Medical Information queries;

• Primary medical expert in addressing safety signal and actions for risk mitigation and management;

• Primary author for the safety sections of IB, clinical study protocol, clinical study report, and eCTD safety summary documents;

• Primary author and point of contact with external stake holder for DSUR;

• Conduct safety signal detection on a routine basis and develop methods for risk mitigation when needed.


• Medical Master a must, Medical Doctoral regress preferred;

• Practice in medicine and knowledge in drug development;

• Good understanding in regulatory requirements and ICH/GCP for safety reporting and pharmacovigilance;

• Good baseline knowledge of scientific literature retrieval and valuation (mainly using PubMed and EMBASE);

• Self-motivated and willing to contribute to patient safety;

• Excellent organization skills with attention to detail;

• Excellent interpersonal and communication skills;

• Fluent in written and verbal English.

>>>Contact Information:
Contact Person:Ginny Ouyang