• 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 Person：Frank Wang