Executive Regulatory Affairs

2 weeks ago


Ho Chi Minh City, Vietnam DKSH Full time

**Location**:Ho Chi Minh, VN, VN**Job Function**:Client and Customer Services**Requisition Number**:143826**Description**:
**Job Summary**
- Manage and archive PV documents and RA/PV SOPs

**General Responsibilities**

**Pharmacovigilance**
- Assume back-up role in the absence of PV main contact
- 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

**Why It’s Great to Work at DKSH**
At DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services we provide, DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference



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