Operations Specialist 1, Pharmacovigilance
hace 3 días
**Job Overview**The Pharmacovigilance and Case Intake Specialist/Operations Specialist 1 reviews, assesses, and processes safety data. This role involves distributing reports/data to internal and external parties, following regulations, SOPs, and guidelines with support from senior team members.**Essential Functions**- Complete assigned training on time.- Process safety data per regulations, guidelines, SOPs, and project requirements.- Perform pharmacovigilance activities, including:- Collecting and tracking Adverse Events (AEs).- Determining status of incoming events.- Database entry and coding AEs/products.- Writing narratives and conducting literature-related activities.- Ensure quality and productivity standards are met.- Comply with all project-related processes and activities.- Read and acknowledge necessary SOPs and ensure timely training.- Create, maintain, and track cases.- Identify and report quality issues.- Demonstrate problem-solving skills.- Liaise with team members and healthcare professionals to address project issues.- May liaise with clients on case processing activities.- Mentor new team members if assigned.- Attend project meetings and provide feedback.- Perform other duties as assigned.- Lead/support department initiatives.- Ensure compliance with all people practices and processes.- Perform medical review of non-serious AEs and ADRs as required.**Qualifications**- Bachelor's degree in life sciences- Up to 1 year in pharmacovigilance and/or intake case processing- Advanced level of English- Good knowledge of medical terminology and safety databases.- Knowledge of global, regional, and local clinical research regulations.- Excellent attention to detail and accuracy.- Strong organizational, time management, and communication skills.- Self-motivated, flexible, and able to work independently.- Ability to multi-task, meet deadlines, and manage competing priorities.- Ability to delegate and adapt to changing demands.- Willingness to learn new skills across safety service lines.- Ability to establish effective working relationships with coworkers, managers, and clients.- Team player with a focus on quality deliverables.- Demonstration of core values in daily tasks.- Extensive use of telephone and face-to-face communication.- Regular sitting for extended periods.- May require occasional travel and flexibility to operate in shifts.LI-Remote
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Operations Specialist 1, Pharmacovigilance
hace 4 días
Desde casa, México IQVIA A tiempo completo**Job Overview** The Pharmacovigilance and Case Intake Specialist/Operations Specialist 1 reviews, assesses, and processes safety data. This role involves distributing reports/data to internal and external parties, following regulations, SOPs, and guidelines with support from senior team members. **Essential Functions** - Complete assigned training on...
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Operations Specialist, Pharmacovigilance
hace 7 días
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, Pharmacovigilance
hace 2 semanas
Desde casa, México IQVIA A tiempo completoExternal Job Description**Job Overview****Key Responsibilities**- Process Safety data as per regulations, guidelines, SOPs, and project requirements.- Perform Pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, database entry, coding AE and Products, writing narratives, and more.- Assess Safety...
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Pharmacovigilance Specialist Argus
hace 3 semanas
Desde casa, México IQVIA A tiempo completo**Your responsibilities will include**:- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.- Database entry and determining initial/update status of incoming events.- Coding AE and Products, writing narratives, literature related activities, quality review, assisting with...
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Operations Specialist 1
hace 3 semanas
Desde casa, México IQVIA A tiempo completoJob OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...
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Sr/safety Operations Specialist
hace 4 días
Desde casa, México IQVIA A tiempo completo**Job Overview****Essential Functions**- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.- Perform pharmacovigilance activities, including collecting and tracking incoming adverse events (AEs) and endpoint information.- Determine initial/update status of incoming events, database entry, coding AEs and...
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Pharmacovigilance Regulatory Reporting
hace 4 días
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 I
hace 3 semanas
Desde casa, México IQVIA A tiempo completo**Please note: This is a Fixed Term role (1 Year)**:**Job Overview**:Review, assess and process safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under...
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Pharmacovigilance Specialist Ssr/sr
hace 2 semanas
Desde casa, México IQVIA A tiempo completoJob Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...
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Safety Aggregate Report Specialist 1
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Job Overview**Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.**Essential Functions**- Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.- Lead, author...