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

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!

Learn more about working at DKSH: https://www.dksh.com/careers

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