Executive Regulatory Affairs & Pharmacovigilance

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

• 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

• 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

• 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

• Diploma/certification of Pharmacy or related disciplines

DKSH