Local Qualified Person for Pharmacovigilance / Pharmacovigilance Officer – Malaysia – Malaysia

Consultant, Strategy Consulting (MY) – Malaysia
March 15, 2023

Local Qualified Person for Pharmacovigilance / Pharmacovigilance Officer – Malaysia – Malaysia


  • Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
  • Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.
  • Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal l products.
  • Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.
  • Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
  • Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
  • Deal directly with the Competent Authority and undergo questioning by regulatory authority inspectors during statutory inspections.
  • Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.
  • Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.


  • Bachelor’s degree in a life-science, medicine, pharmacy or nursing or educational equivalent.
  • Around 4 years relevant clinical experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
  • Resident in Malaysia with fluent Bahasa Malaysia skills & excellent command of the English language
  • In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
  • Excellent knowledge of the pharmacovigilance legal framework in the EU and in Malaysia.
  • Solid knowledge of relevant Standard Operating Procedures (SOPs).
  • Possess excellent written and verbal communication skills.
  • Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections.
  • Strong organizational and project management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, customers and third parties
  • Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
  • Demonstrate an understanding of compliance and of quality management systems
  • Availability by phone 24/7 for Competent Authority enquiries
  • May require some travel

To apply for this job email your details to mitech2u@gmail.com