Responsibilities:

• 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.

Requirements:

• 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