Pharmacovigilance Local Contact Person With Hungarian And English Language

2+ years

Not Disclosed

Budapest

10 Nov. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Local Contact Person (Qualified Person) - Hungary - IQVIA

As the Pharmacovigilance Local Contact Person, you will serve as the local Qualified Person for customers requiring pharmacovigilance services for their products. You will ensure that safety standards are met and that communication with regulatory authorities is handled efficiently and promptly.

Key Responsibilities:

Act as the local Qualified Person according to the requirements outlined in the IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
Be available 24/7 to receive calls from the local Competent Authority as needed.
Serve as the point of contact during pharmacovigilance inspections, handling direct interactions with inspectors during statutory inspections.
Respond fully and promptly to Competent Authorities' requests to assess the benefits and risks of medicinal products, including post-authorization safety studies and information about sales or prescriptions.
Ensure that your name and contact details are notified to the Competent Authority when the contract begins.
Stay updated on changes in local regulatory requirements and ensure necessary safety measures, risk management plans, and regulatory compliance are implemented.
Develop and maintain a thorough understanding of each project’s budget and Scope of Work (SOW). Manage project materials such as files, templates, databases, and workflow.
Provide regular project reports to the Project Manager, including updates on project metrics, SOW changes, and customer requests.
Provide monthly updates to the EU QPPV or designee and complete necessary regulatory reports.

Minimum Required Education and Experience:

Bachelor’s degree in life sciences, medicine, pharmacy, nursing, or an educational equivalent.
At least 2 years of relevant experience, including managing clinical trial safety or post-marketing safety, or a combination of education and experience.
Fluent Hungarian language skills (at least C2 level) and excellent English (min. C1).
In-depth knowledge of global, regional, and local regulatory requirements, as well as the pharmacovigilance legal framework in the EU and Hungary.
Solid understanding of Standard Operating Procedures (SOPs).
Ability to assess the safety profile of products and monitor factors influencing the benefit/risk balance.
Understanding of compliance and quality management systems.
Available 24/7 for Competent Authority inquiries.

About IQVIA: IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights, helping improve patient outcomes worldwide by accelerating the development and commercialization of innovative medical treatments. Learn more and apply here.

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Pharmacovigilance Local Contact Person With Hungarian And English Language

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