Local Qualified Person for Pharmacovigilance with Czech and/or Slovak and fluent English language

As the Local Qualified Person (QP) for Pharmacovigilance 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

· 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 Slovakia with fluent Czech and/or Slovak language skills (at least C2).

· Very good knowledge of the English language.

· In-depth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.

· Knowledge of the pharmacovigilance legal framework in the EU and in Slovakia.

· Knowledge of relevant Standard Operating Procedures (SOPs).

· 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

To apply, please kindly send us your most updated CV in English language.