RA/ PV Officer/ Executive

Job Description

HCM: 1 position, Ha Noi: 1 position

Regulatory Affairs:

• Support manager in preparing SIQ documents, submit SIQ applications to MOH/ Department of Health of HCM city
• Prepare, submit and follow up GMP assessment for all manufacturers and follow up with MOH
• Key person to contact to MOH/ Department of Health of HCM city regarding SIQ and other RA activities in competent authorities
• Build good relationships with experts of health authorities and competent authorities for better work efficiency.
• Cooperate with RA team in preparing GMP assessment for all manufacturers
• Cooperate with relevant departments (marketing, sale team) to prepare advertising documents. Support and update necessary documents for hospital tender.
• Update reports, systems as required
• To get stamp, signature of General Director and DSTH Chief VRO for all RA documents
• Other tasks assigned by manager

Pharmacovigilance:

• Support Local Safety Officer regarding risk Management Measures of Oncology products.
• Attend PV meeting and training from CSPV
• Collect ADR cases of assigned products from FF/Marketing/partners
• Handle queries about safety information of assigned products, inform CSPV about updating safety information of assigned products, prepare PSUR reports and Form 2A of assigned products, submit to National ADR Center.
• Reconciliation with externally and internally
• Literature search in local journals
• Prepare PV training materials for assigned product, support manager to conduct PV training, support Local Safety Officer to prepare for PV audit

Job Requirement

• Graduated from college or university (Bachelor’s degree of Pharmacy preferred)
• About 1-2 years’ experience as similar position in MNC
• MS Office (Outlook, PowerPoint, Excel and Word) proficiency
• Good communication skills in Vietnamese and English
• Good relationship with MOH or Deparment of Health of HCM city is advantage.
• Be diligent, hard working, honest, self-disciplined