>>>Location：Shanghai
【Responsibilities】
? 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.
【Qualification】
? 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
Mobile：15680922101
Mail：frank.wang@isaac-kenneth.com
