药物警戒/药物安全(Pharmacovigilance)

面议 上海浦东新区 应届生 本科 全职

药物警戒/药物安全(Pharmacovigilance)

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职位亮点
五险一金 节日福利 带薪年假 定期体检 弹性工作
职位描述
Responsibility:
• Responsible for day-to-day adverse experience case management withinthe country(ies) covered by the country operation including case intakeand follow-up activities in accordance with Global Safety procedures,the review of local literature as per client’s procedure and countryregulations, and health authority submissions of cases in accordancewith Global Safety procedures and health authority requirements.
• Responsible for aggregate safety report submissions in thecountry(ies) in accordance with Global Safety procedures and healthauthority requirements.
• Responsible for the reconciliation of adverse events reports receivedfrom other client’s operating units (e.g., Designated Point of Contact,Medical Information, etc.) and contractual partners, as applicableResponsible for the filing, storage and archiving of safety-related datain accordance with client’s policies and local requirements.
• Serve as the local Deputy Qualified Person for PV (QPPV) / deputylocal responsible PV person for the country(ies) when delegated by PVCountry Lead.
• Serve as back-up in the absence of the PV Country Lead to ensurebusiness continuity.
• Responsible for being compliant with local PV regulations, clientpolicies and procedures and Global Safety procedures at the countrylevel.
• Participate in individual case safety report compliance activities andtakes the necessary corrective actions locally for the late reportingwithin the country(ies) covered by the country operation.
• Assist in preparation for audits/inspections for theircountry/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 facingnon-PV staff (e.g., Sales Reps, Medical Information, etc.) anddistributors / vendors / business partners in the country(ies) withinscope.
• Complete and document required PV training within the requiredtimelines. Perform other activities as requested by the PV Country Lead.
Education:
• The incumbent must have a health, life science, or medical sciencedegree or equivalent by education / experience.
Experience:
• Fresh graduates are welcomed.
• 0.5-1 year of pharmaceutical industry experience preferred, especiallyexperience as PV.
• He/she must have an awareness of Pharmacovigilance regulations withinhis/her assigned country(ies).
• The PV Specialist is expected to have strong communication and timemanagement skills, and have the ability to work independently withminimal supervision.

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职位要求
  • 药学

  • 本科

  • 应届生

  • 不限

工作地址

上海浦东新区张江高科亮景路199号 查看地图

联系人

科文斯医药研发(北京)有限公司上海分公司

制药/生物工程

医药企业 其他

1000~9999人

近两周简历处理率 56%
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