Local Qualified Person (QP) for Pharmacovigilance / Pharmacovigilance Officer

As the Local Qualified Person (QP) for Pharmacovigilance/Pharmacovigilance Officer you will act as local Qualified Person for customers requiring the services for their product.

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.

· 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

· Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.

· 4 years relevant clinical experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.

· Resident in Latvia with fluent Latvian language skills (at least C2).

· Excellent command of the English language.

· Knowledge of applicable global, regional and local regulatory requirements, International Conference on Harmonization (ICH) guidelines, and the pharmacovigilance legal framework in the EU and in Latvia.

· Solid knowledge of relevant Standard Operating Procedures (SOPs).

· Ability to maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product.

· Understanding of compliance and of quality management systems.

· Availability by phone 24/7 for Competent Authority enquiries.

· Resident in Latvia.

· May require some travel.   

#LI-Remote #LI-Hybrid #LI-Onsite

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com