RA/ PV Officer/ Executive

HCM: 1 position, Ha Noi: 1 position
Regulatory Affairs:

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

Pharmacovigilance:

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.
Literature search in local journals
Support Local Safety Officer regarding risk Management Measures of Oncology products.
Attend PV meeting and training from CSPV
Reconciliation with externally and internally
Prepare PV training materials for assigned product, support manager to conduct PV training, support Local Safety Officer to prepare for PV audit
Collect ADR cases of assigned products from FF/Marketing/partners

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

Laptop, Chế độ bảo hiểm, Du Lịch, Phụ cấp, Du lịch nước ngoài, Đồng phục, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Công tác phí, Nghỉ phép năm

Cập nhật gần nhất lúc: 2024-08-25 21:25:02