职位描述
Responsibility:
Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per client’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
Responsible for the reconciliation of adverse events reports received from other client’s operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable Responsible for the filing, storage and archiving of safety-related data in accordance with client’s policies and local requirements.
Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead.
Serve as back-up in the absence of the PV Country Lead to ensure business continuity.
Responsible for being compliant with local PV regulations, client policies and procedures and Global Safety procedures at the country level.
Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection. Identify and communicate potential safety issues to PV Country Lead. Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
Complete and document required PV training within the required timelines. Perform other activities as requested by the PV Country Lead.
Education:
Experience:
Fresh graduates are welcomed. 0.5~1 year of pharmaceutical industry, PV experience preferred.
He/she must have an awareness of Pharmacovigilance regulations within his/her assigned country(ies).
The PV Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.
※We also have 1 opening in Beijing. One in Beijing would require at least half year experience as PV specialist.
企业简介
科文斯，全球性的合同研究组织（CRO）Covance Inc.是全球服务最全面的药物研发公司。
我们致力于推动医疗保健事业发展并实现Solutions Made Real®，通过向制药公司和生物科技公司提供高质量的非临床、临床前试验、临床和商业化服务，帮助减少药物研发的时间和成本。凭借丰富的经验与深厚知识，我们具备独特的优势，能为客户合作伙伴提供不仅仅局限于测试的独到见解。
我们还向化学品、农用化学品和食品行业提供实验室测试服务，同时也是毒理学分析服务、中心实验室服务、药物筛选服务的市场领导者，以及III期临床试验管理服务的全球顶级提供商。
科文斯官网： https://www.covance.com/
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