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As a Local Qualified Person (QP) for Pharmacovigilance in Poland 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.

·  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 Poland with fluent Polish language skills (at least C2).

·  Excellent command of the English language.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

· 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 Poland.

· 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

PHYSICAL REQUIREMENTS

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

· Resident in Poland.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com