Clinical Safety Manager

•Assist in the establishment of the company's pharmacovigilance system to ensure the implementation of pharmacovigilance;

• Establish and timely update the company's PV-related processes and SOPs and other controlled documents in accordance with regulatory and regulatory requirements to ensure process optimization;

• Evaluate and report ICSRs from the clinical trial phase and post-marketing products, and ensure that the ICSR is reported to the relevant regulatory authorities within the specified timeline as required by the regulations;

• Analyze and evaluate product safety data, perform signal detection, and develop effective risk control measures;

• Preparation and submission of safety-related documents (e.g.DSUR, PSUR, RMP, etc.);

• Review of pharmacovigilance related documents (such as protocol, investigator's brochure,SAE reconciliation plan, etc.);

• Assist in the preparation of pharmacovigilance related documents required for IND/BLA to support product application and post-marketing re-registration; 

• Responsible for the annual report of pharmacovigilance;

• Provide pharmacovigilance training for relevant personnel within and outside the company;

• Assist the QPPV to cooperate with the audit and verification by regulatory authorities;

• Assist the QPPV to manage the pharmacovigilance team and ensure the orderly progress of various work;

• Focusing on the key objectives of project management, ensure the effective implementation of project safety work through cross-departmental cooperation and effective communication between internal and external customers.

• Review the project safety management plan and other relevant documents, such as the review of the safety part of the protocol.