1. Compliance
Ensure compliance with the applicable pharmacovigilance SOPs
Ensure and monitor pharmacovigilance compliance with local regulations.
Notify regional RPP regarding any new or updated national pharmacovigilance requirements for the countries of responsibility.
Ensure that any communication from local regulatory authority related to Pharmacovigilance is communicated to Regional RPP and is promptly and adequately addressed.
2. Adverse drug reaction management
Follow-up local ADR cases for further clarification with the reporter and HCPs and completeness.
Forward ADR information collected to the Regional Pharmacovigilance office.
3. Pharmacovigilance reports management
Report processed ADRs to the local regulatory authorities, as applicable, in accordance with local regulations and maintain a submission log.
Ensure timely submission of the periodic safety reports received, as applicable, to local regulatory authorities and maintain a submission log.
Comply with the timelines specified in this regard in the applicable pharmacovigilance SOPs and regulations.
4. SDEA management for China
5. Others arranged by team leader
1.遵守
确保符合适用的药物警戒SOP
确保并监督药物警戒符合当地法规。
就责任国的任何新的或更新的国家药物警戒要求通知区域RPP。
确保与药物警戒相关的当地监管机构的任何通信均传达给区域RPP，并及时、充分地处理。
2.药物不良反应管理
跟进当地ADR案例，与报告人和医务人员进一步澄清，并确保完整性。
将收集的ADR信息转发给区域药物警戒办公室。
3.药物警戒报告管理
根据当地法规向当地监管机构报告处理后的ADR（如适用），并保存提交日志。
确保及时向当地监管机构提交收到的定期安全报告（如适用），并维护提交日志。
遵守适用的药物警戒SOP和法规中在这方面规定的时间表。
4.SDEA中国管理
5.其他等
PV Executive
Fresh graduate or 1 year experience
Major in Science or Pharmacy
Good English