職位描述
Responsibilities：
?Process and distribute safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies, and procedures.
?Triage domestic and foreign safety reports received by the client and reporter, appropriately scheduling case reports in the safety database based on the following criteria: source, seriousness, data entry priority, initial vs. follow-up report.
?Responsible for initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy, legibility, and consistency of information, and perform necessary checks for duplicate cases.
?Exercise judgment and use knowledge of applicable regulations and ICH guidelines and product labeling in performing initial case assessment for seriousness and expectedness / listedness.
?Enter appropriate data into the safety database in a timely manner, utilizing management-determined data entry guidelines.
?Generate narrative case summaries according to Wuxi-PRA standards.
?Code all adverse event terminology, other medical information, and drug information in the safety database utilizing MedDRA and WHO-DD dictionaries, in accordance with the coding policies and standards.
?Liaise with assigned Physicians in Drug Safety, Clinical Science and/or Medical Affair to ensure that appropriate medical review and assessment is provided for assigned case reports.
?Determine necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge.
?Perform follow-up as needed, either directly with reporter, through Call Center, client, or through appropriate CRAs, and documents results in case file.
?Ensure that required follow-up for assigned cases has been completed.
?Communicate with partner companies, client, and manager regarding the evaluation and processing of case reports.
?Create and maintain electronic and/orhard copy case files as per the client SOPs and guidelines.
?Produce and distribute expedited and non-expedited individual case safety reports to regulatory authorities, partner companies, EC, investigators, and clients, as needed, to ensure compliance with regulatory and company timelines.
?Cooperate with clinical data management to conduct SAE reconciliation.
任職要求：
1、臨床醫(yī)學本科及以上學歷；
2、CET6，英語流利；
3、善于學習，有責任心，良好的溝通協(xié)調(diào)能力。
