CN Shanghai Senior Pharmacovigilance Specialist

Job description

博士伦隶属于博士伦公司（NYSE/TSX: BLCO），是中国最知名和最受尊敬的医疗保健公司之一。我们为客户提供最全面和最优质的眼科保健产品，包括隐形眼镜和镜片护理产品，药品，人工晶状体和其他眼科手术产品。我们的首要任务是为我们所服务的人群创造福祉。通过倾听客户和患者的心声，通过不断磨练我们的创新优势，通过诚信和卓越的执行，我们努力赢得我们的合作伙伴和利益相关者的信任。 Act as (deputy) Local PV contact person/ (deputy) LPPV/ deputy Qualified Person for Pharmacovigilance in China (China QPPV), as required, to perform, document and escalate applicable PV activities in accordance with applicable Chinese regulations, global procedures, and company requirements. Responsibilities: Receive, translate, and forward Individual Case Safety Reports (ICSRs) concerning applicable medicinal products, cosmetics, biocides, nutritionals in China to Global Pharmacovigilance & Risk Management (GPRM) and/or the applicable partner(s); conduct follow-up for ICSRs/ Special Situation reports including applicable targeted questionnaires, reconcile, submit to local regulatory authorities and/ or the applicable partner(s), and document. Support of E2B submissions, as necessary. Coordinate the scheduling, preparation and submission of aggregate reports by providing requested data to GPRM and/or the applicable partner; reviewing and translating reports; preparing submission packages; submitting reports to local regulatory authorities and/or applicable partners; track and maintaining the required documentation, as applicable. Support labeling update activities and maintain Reference Safety Information in accordance with GPRM requirements. Participate in GPRM training activities and regular teleconferences organized by GPRM. Implement and maintain the local risk management system by supporting Direct Healthcare Professional Communication (DHPC), routine and additional risk minimization measures (e.g. educational materials, etc.) according to Risk Management Plan (RMP, in cooperation with GPRM Risk Management Team, other departments and partners, as applicable). Collaborate with Medical Affairs and Regulatory Affairs to support timely completion of RMP activities. Provide local support for activities related to global RMP preparation. Track, and document RMP activities, including evidence of completed activities. Review risk management plans and aggregate reports to understand the risk-benefit profile of products. Support Corporate PSMF updates and review the country-specific annexes as required by local requirements, if applicable. Support with timely update of China PSMF, as necessary. Perform and/or organize local literature searches; maintain, review, update, and document the local literature search list. Organize PV training for local employees and partners to meet company SOPs, local and international laws and guidelines, as required. Acting as a local PV contact person or local Qualified Person for PV for local regulatory authorities as required, within the authorized scope and applicable internal review and escalation procedures. Monitor changes in the local regulatory environment and notify GPRM of relevant new or revised safety requirements. Participate in safety-related actions, including withdrawals and recalls, as applicable. Communicate any urgent safety issues to GPRM, local management and/or applicable stakeholders, and support communication with local regulatory authorities in accordance with applicable internal procedures and regulatory requirements. Support review of local Safety Data Exchange Agreements (SDEAs), monitor compliance in cooperation with Global Vigilance Agreement Team (GVA) and inform GVA of any new executed SDEAs. Act as a local contact point for audits and inspections and related processes and inform GPRM PV Compliance Team and reginal liaison team, and handle audits and inspections by coordinating documentation, meetings, CAPA management and follow-up activities. Perform PV activities in accordance with local applicable SOPs and work instructions. Maintain and improve the reconciliation process for labeling updates resulting from signal detection. Support implementation of GPRM vigilance system improvements. Inform GPRM regarding changes in local responsible persons. Ensure update of PV related local SOPs, CV, JD and local Org Chart on a regular basis or if required to make sure the fully compliance on local regulatory requirement and global policy. 博士伦公司致力于利用多元化员工的才能为我们的业务和员工创造良好的机会。所有合格的申请人都将获得就业考虑，不论其种族，肤色，宗教，性别，性取向，性别认同，国籍，残疾或退伍军人身份。 立即申请 » 查找类似职位: 바슈앤롬, Carrières chez Bausch & Lomb, Carreras Bausch & Lomb, Bausch und Lomb, Bausch & Lomb 联系我们 法律声明 隐私政策 站点地图 Cookie 许可管理器 当您访问任何网站时，它可能存储或检索浏览器中的信息，大多数为 cookie 形式。我们尊重您的隐私权，因此您可以选择不允许某些类型的 cookie。但是，阻止某些类型的 cookie 可能影响您的网站体验以及我们能够提供的服务。 需要的 Cookie 需要这些 cookie 才能使用此网站，无法将其关闭。 需要的 Cookie 需要的 Cookie 提供者 描述 已启用 SAP as service provider 我们使用以下会话 cookie，使网站正常工作需要所有这些 cookie： "route" 用于会话粘性 "careerSiteCompanyId" 用于将请求发送至正确的数据中心 "JSESSIONID" 在会话期间位于访问者的设备上，以便服务器能够识别访问者 "Load balancer cookie"（实际的 cookie 名称可能不同）阻止访问者从一个实例跳转到另一个实例 需要来自提供者 SAPasserviceprovider 的 cookie，无法将其关闭