概要

• 給与

  -

• 業界

  Manufacturing(Pharmaceutical/MedicalEquipment)

• 仕事内容

  【Job Summary】
  - Responsible for Regulatory Affairs, Pharmacovigilance, and other tasks
  
  【Job Summary】
  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 health authorities experts for better work efficiency.
  - Cooperate with relevant departments (marketing, sales team) to prepare advertising documents. Support and update necessary documents for hospital tender.
  - Update reports, and systems as required
  - Conduct the regulatory surveys, communicate with regional for assigned products
  - Other tasks assigned by the manager.
  
  2. Pharmacovigilance:
  - Support the local safety officer regarding PV SOP and PV agreement, update local regulations about PV, assess the impact on local SOP, manage compliance with SOP and local regulations, signal detection, and risk management measures of oncology products.
  - Attend PV meetings 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, and submit to the National ADR Center.
  - Literature search in local journals
  - Prepare PV quarterly report, PV training materials for assigned products, and support manager to conduct PV training, support Local Safety Officers to prepare for PV audit.
  
  3. Other activity
  - Do other activities as an office admin.
  
  【Company/Job Attraction】
  - Comprehensive benefits program, Bonus twice a year in June and Dec (Max total bonus per year: 3 months salary)
  - Comprehensive, relevant learning and performance-improvement resources and on-the-job development opportunities
  - Opportunities for promotion, and income improvement for competent, enthusiastic, and long-term people