職位描述
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.
企業簡介
科文斯，全球性的合同研究組織（CRO）Covance Inc.是全球服務最全面的藥物研發公司。
我們致力于推動醫療保健事業發展并實現Solutions Made Real?，通過向制藥公司和生物科技公司提供高質量的非臨床、臨床前試驗、臨床和商業化服務，幫助減少藥物研發的時間和成本。憑借豐富的經驗與深厚知識，我們具備獨特的優勢，能為客戶合作伙伴提供不僅僅局限于測試的獨到見解。
我們還向化學品、農用化學品和食品行業提供實驗室測試服務，同時也是毒理學分析服務、中心實驗室服務、藥物篩選服務的市場領導者，以及III期臨床試驗管理服務的全球頂級提供商。
科文斯官網： https://www.covance.com/
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