Location: Latvia
Availability: 24/7
As the Pharmacovigilance Local Contact Person at IQVIA, you will serve as the local Qualified Person for pharmacovigilance services, ensuring compliance with regulatory standards and acting as the primary liaison for product safety matters.
Qualified Person Role: Act as the local Qualified Person in accordance with the requirements outlined in the IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
Regulatory Liaison: Be available 24/7 to handle calls from the local Competent Authority. Serve as the primary contact during pharmacovigilance inspections and interact directly with Competent Authority inspectors.
Regulatory Compliance: Respond promptly and comprehensively to Competent Authority requests regarding the benefit-risk profile of medicinal products, including information on sales, prescriptions, and post-authorization safety studies.
Contact Information: Ensure your name and contact details are communicated to the Competent Authority at the start of the contract.
Regulatory Updates: Stay current with local regulatory changes. Ensure safety mechanisms and risk management plans are updated and effectively implemented.
Project Management: Develop and maintain a detailed understanding of project budgets and scopes of work (SOW). Organize and manage project materials, including files, forms, templates, and databases.
Reporting: Provide regular updates to the project manager on project metrics, SOW modifications, customer requests, and any concerns. Deliver monthly updates to the EU QPPV or designee and complete necessary regulatory reports.
Education: Bachelor's degree in life sciences, medicine, pharmacy, nursing, or a related field.
Experience: Approximately 2 years of relevant experience in managing clinical trial safety or post-marketing safety, or an equivalent combination of education and experience.
Language Skills: Fluent in Latvian (C2 level) and proficient in English (minimum C1 level).
Regulatory Knowledge: Strong understanding of global, regional, and local regulatory requirements, as well as the pharmacovigilance legal framework in the EU and Latvia.
SOP Knowledge: In-depth knowledge of relevant Standard Operating Procedures (SOPs).
Safety Management: Ability to maintain an overview of product safety profiles 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. We connect people and data to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and global health. For more information, visit IQVIA Careers.
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