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
確保符合適用的藥物警戒SOP
確保并監(jiān)督藥物警戒符合當(dāng)?shù)胤ㄒ?guī)。
就責(zé)任國(guó)的任何新的或更新的國(guó)家藥物警戒要求通知區(qū)域RPP。
確保與藥物警戒相關(guān)的當(dāng)?shù)乇O(jiān)管機(jī)構(gòu)的任何通信均傳達(dá)給區(qū)域RPP,并及時(shí)、充分地處理。
2.藥物不良反應(yīng)管理
跟進(jìn)當(dāng)?shù)谹DR案例,與報(bào)告人和醫(yī)務(wù)人員進(jìn)一步澄清,并確保完整性。
將收集的ADR信息轉(zhuǎn)發(fā)給區(qū)域藥物警戒辦公室。
3.藥物警戒報(bào)告管理
根據(jù)當(dāng)?shù)胤ㄒ?guī)向當(dāng)?shù)乇O(jiān)管機(jī)構(gòu)報(bào)告處理后的ADR(如適用),并保存提交日志。
確保及時(shí)向當(dāng)?shù)乇O(jiān)管機(jī)構(gòu)提交收到的定期安全報(bào)告(如適用),并維護(hù)提交日志。
遵守適用的藥物警戒SOP和法規(guī)中在這方面規(guī)定的時(shí)間表。
4.SDEA中國(guó)管理
5.其他等
PV Executive
Fresh graduate or 1 year experience
Major in Science or Pharmacy
Good English