Executive Regulatory Affairs & Pharmacovigilance

DKSH

Ho Chi Minh City
Permanent
Full-time

8 days ago

Job Summary

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

General ResponsibilitiesPharmacovigilance

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 DKSHAt 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!Learn more about working at DKSH: https://www.dksh.com/careers#LI-TP1Requisition Number: 194056Job Function: Client and Customer Services

DKSH

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