The RA / PV Executive is responsible for ensuring the regulatory compliance and pharmacovigilance of assigned pharmaceutical products. This role involves the preparation and submission of regulatory dossiers, management of Good Manufacturing Practice (GMP) assessments, and the maintenance of strong relationships with health authorities.
Responsibilities:
1. Regulatory Affairs:
- Prepare, submit, and follow up registration dossier of the assigned products with MOH.
- Prepare, submit and follow up GMP assessment for all manufacturers and follow up with MOH.
- Build good relationships with experts of health authorities for better work efficiency.
- Cooperate with relevant departments (marketing, sale team) to prepare advertising documents. Support and update necessary documents for hospital tender.
- Update reports, systems as required.
- Conduct the regulatory surveys, communicate with regional for assigned products.
- Other tasks assigned by manager.
2. Pharmacovigilance:
- Support Local Safety Officer regarding PV SOP, PV agreement, updating local regulation about PV and assessing the impact to local SOP, managing the compliance with SOP and local regulations, signal detection, 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.
- Literature search in local journals.
- Prepare PV quarterly report, PV training materials for assigned product, support manager to conduct PV training, support Local Safety Officer to prepare for PV audit.
3. Other activity
- Do other activities as an office admin.
