RA/ PV Officer/ ExecutiveCông Ty TNHH Daiichi Sankyo Việt Nam

Mô tả Công việc
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
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
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