Title:  Executive Regulatory Affairs & Pharmacovigilance

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