Location: Hungary
Availability: 24/7
As the Pharmacovigilance Local Contact Person at IQVIA, you will serve as the local Qualified Person, ensuring compliance with pharmacovigilance regulations and acting as the primary contact for regulatory matters related to product safety.
Qualified Person Role: Serve as the local Qualified Person according to the guidelines in the IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
Regulatory Liaison: Be available 24/7 to respond to calls from local Competent Authorities. Act as the main contact for pharmacovigilance inspections, interacting directly with inspectors during statutory inspections.
Regulatory Compliance: Respond promptly and thoroughly to Competent Authority requests regarding the benefit-risk profile of medicinal products, including information on sales, prescriptions, or post-authorization safety studies.
Contact Details Management: Ensure your name and contact details are communicated to the Competent Authority upon contract initiation.
Regulatory Awareness: Stay informed about changes in local regulatory requirements and ensure that necessary safety mechanisms and risk management plans are implemented.
Project Management: Understand and manage each project's budget and scope of work (SOW). Organize project materials, including files, forms, templates, databases, and workflows.
Reporting: Provide regular updates to the project manager on project metrics, changes to the SOW, customer requests, and concerns. Communicate monthly updates to the EU QPPV or designee and complete regulatory reports as required.
Education: Bachelor’s degree in life sciences, medicine, pharmacy, nursing, or a related field.
Experience: Approximately 2 years of relevant experience in clinical trial safety or post-marketing safety, or an equivalent combination of education and experience.
Language Skills: Fluent in Hungarian (C2 level) and proficient in English (minimum C1 level).
Regulatory Knowledge: In-depth understanding of global, regional, and local regulatory requirements, as well as the pharmacovigilance legal framework in the EU and Hungary.
SOP Knowledge: Solid knowledge of relevant Standard Operating Procedures (SOPs).
Safety Profile Management: Ability to oversee the safety profile of products and assess factors affecting the benefit-risk balance.
Compliance Understanding: Familiarity with compliance and quality management systems.
Availability: Must be available by phone 24/7 for inquiries from Competent Authorities.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. We facilitate the development and commercialization of innovative medical treatments to improve patient outcomes and global health. For more information, visit IQVIA Careers.
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Arkansas | Remote Australia |Republic of Western Australia :
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