Position 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 tenders.
• Update reports, and systems as required
• Conduct the regulatory surveys, communicate with regional for assigned products
• Other tasks assigned by the manager not limited to:
  • Keeping pace with regulatory requirements.
  • Ensure approval of registration applications of all medicines in applicable countries.
  • Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines
  • Ensure compliance with quality requirements on release of medicine for sale in line with GMP and company policies and procedures.
  • Prepare and update data for MDR, MIMS or any other external product database for all marketed products in liaison with the Regulatory Affairs Head.
  • Establish and maintain effective relationships with all stakeholders

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.

Requirement

- Bachelors degree in Pharmacy or course related to the pharmaceutical field
- At least 2 years experience in a similar position (Regulatory Affairs & Pharmacovigilance) in MNC companies
- MS Office (Outlook, PowerPoint, Excel, and Word) proficiency.

Soft Skills Required

• Organizational skills
• Communication skills
• Observation skills
• Analytical skills
• Compassionate