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

Report to CMO

Previous: Drug Safety and Pharmacovigiliance (AD to ED Level)

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Drug Safety and Pharmacovigiliance (AD to ED Level)