Operations Specialist 2, Regulatory Reporting
hace 2 semanas
**Job Overview****Essential Functions**- Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases.- Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with requirements.- Liaise with local IQVIA offices and relevant stakeholders to facilitate expedited reporting.- Perform quality control of safety data and ensure compliance with IQVIA high-quality standards.- Generate status reports, provide project metrics to PVS Leads, and assist LS management with Safety Management Plan (SMP) reviews.**Qualifications**- Bachelor’s Degree in a scientific or healthcare discipline or allied life sciences required.- Up to 5 years of relevant experience, including up to 3 years of Pharmacovigilance experience required.- Advanced level of English- In-depth knowledge and understanding of applicable Safety Database, global, regional, and local clinical research regulatory requirements.- Excellent organizational skills, time management skills, attention to detail, and accuracy.- Proven ability to work independently, multi-task, meet strict deadlines, and manage competing priorities.LI-Remote
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Regulatory Reporting Specialist, Mexico
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Job Overview** - As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities._ Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs),...
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Pharmacovigilance Regulatory Reporting
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Job Overview**- As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities._Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and...
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Operations Specialist, Pharmacovigilance
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Job Overview** We are seeking a dedicated and detail-oriented professional to join our team as a Operations Specialist 1. In this role, you will provide critical phone support to healthcare professionals and patients, handling medical inquiries, adverse events, product quality complaints, and other relevant calls. This position does not involve commercial...
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Operations Specialist 2
hace 3 días
Desde casa, México IQVIA A tiempo completoJob Overview Essential Functions - Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. - To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information - determining...
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Regulatory Affairs Specialist
hace 1 semana
Desde casa, México ICON A tiempo completoAs a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- Regulatory advice to drug development is key to ensuring our clients pursue first time right strategies to overall product development and to clinical programme...
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Regulatory Affairs Specialist
hace 3 semanas
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico.**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...
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Regulatory Affairs Specialist
hace 3 semanas
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM.**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...
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Regulatory Specialist 2, Fsp
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Job Overview**Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.**Essential Functions**- Under general supervision,...
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Regulatory & Start Up Specialist 2, Cfsp
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Regulatory & Start Up Specialist, c**FSP - US/CAN Support** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site...
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Remote Claims Operations Specialist
hace 3 días
Desde casa, México Hire Latam LLC A tiempo completo_**HireLatam is a premier recruitment agency that connects exceptional talent in Latin America with outstanding opportunities in the United States. With a proven track record and a commitment to excellence, we're your trusted partner in the pursuit of career success. Our extensive network, personalized approach, and supportive guidance ensure that you're in...