Executive Regulatory Affairs

2 weeks ago


Ho Chi Minh City, Ho Chi Minh, Vietnam DKSH Full time ₫1,200,000 - ₫3,600,000 per year

Location:
Ho Chi Minh, VN, VN

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 218756

Description:

Job Summary
  • To be deputy person for Pharmacovigilance (PV) and Regulatory Affairs (RA) tasks
  • Manage and archive PV documents and RA/PV SOPs
General Responsibilities
  • Pharmacovigilance

  • Receive, follow up Safety reporting case

  • Prepare Safety reports for submission to Clients, relevant authority
  • Assist PV training and Client audit
  • Perform internal and external reconciliation of Safety reports
  • Perform literature review
  • Manage and archive PV documents and SOPs
  • Other tasks as assigned by line manager

Regulatory Affairs

  • Support to prepare symposium dossiers (if required)
  • Manage RA SOPs
  • Support admin part assigned by managers: PV payment, scan/ photocopy & archive reg. dossiers,…
  • Other tasks assigned by managers
Functional Skills and Knowledge
  • At least 3 year of experience in relevant field (safety experience includes actual experience processing Adverse events reports and experience with regulatory affairs tasks)
  • Knowledge of relevant RA/PV regulation
  • Good at English & Microsoft offices
Education
  • Diploma/certification of Pharmacy or related disciplines

Requisition Number: 218756

Job Function: Regulatory Services



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