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Drug Safety Assistant /Senior Drug Safety specialist





• Process Safety data according to applicable regulations,guidelines, Standard Operating procedures (SOPs) and Sinovent requirements.

• Enters information into PVG quality and tracking systems for receipt and tracking ICSR.

• May assist in the preparation of the Safety Management Plan .

• Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.

• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.

• Enters data into safety database.

• Codes events, medical history, concomitant medications and tests.

• Compiles complete narrative summaries.

• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.

• Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.

• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.

• Support Senior Management as required.

• Prioritize and complete the assigned trainings on time.

• Attend team meetings and provide feedback to operations manager on any challenges/issues or successes.

• Lead/ Support department Initiatives.

• Participate in audits/inspections as required.

• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per SOP for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.

• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

• Perform other duties as assigned.


• Bachelor's degree or educational equivalent in health science or other directly related field or equivalent combination of education, training or experience.

• Safety database system experience (Argus is preferred).

• Good knowledge of domestic and global Pharmacovigilance regulations (GCP/GVP/GPSP), CDE・NPMA/FDA/EMA regulations, ICH Guidelines.

• Minimum of 1-3 year(s) global pharmacovigilance experience or other equivalent clinical or pharmaceutical industry experience.

• Excellent verbal and written communication skills.

• Fluency in written and verbal English.

• Good computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point)

• Good organizational, time management, and problem-solving skills.

>>>Contact Information:
Contact Person:Frank Wang