Executive Regulatory Affairs
2 weeks ago
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
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
- 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
Requisition Number: 218756
Job Function: Regulatory Services
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