>>>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
