Pharmacovigilance Specialist

IQVIA Thailand is looking to hire a Local Contact for Pharmacovigilance, act as the local contact for customers requiring the services for their product(s). You will develop and prepare pharmacovigilance agreements for assigned customers, prepare pharmacovigilance systems master files under direct supervision.

Responsibilities:

• 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.
• 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.
• Work in a collaborative team environment with project team members both remotely and onsite; lead by example; assist management with allocating resources to projects. Will be required to work independently within the Qualified Person for Pharmacovigilance (QPPV) role.
• Proactively identify issues and propose solutions. Respond promptly and effectively to all requests.
• Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner;
• Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.
• Support pharmacovigilance operations as required.

Requirements:

• Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.
• Around 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.
• Excellent written and verbal skills in English and Thai.
• In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
• Very good knowledge of the pharmacovigilance legal framework in Thailand.
• Strong knowledge of relevant Standard Operating Procedures (SOPs).
• Excellent analytical and problem-solving approach when interpreting safety reports, literature and undergoing inspections
• Demonstrate ability to work independently as well as within teams
• Strong organizational and project management skills
• Demonstrate confidence, professionalism and credibility whilst interacting with customer 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