>>>Location：Shanghai
【Responsibilities】
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.
【Qualification】
? 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
Mobile：15882001985
Mail：ginny.ouyang@isaac-kenneth.com
