Job 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
汇报对象:CMO
Previous: 药物安全与警戒 (副总监~执行总监)
Others
-
药物安全与警戒 (副总监~执行总监)
Retract