Pharmacovigilance Associates/senior Associates

hace 7 días

Iztapalapa, Ciudad de México Icon plc A tiempo completo
ICON plc is a world-leading healthcare intelligence and clinical research organization.

From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.


With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.


Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.

ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are looking for Associates and Senior Associates for the Pharmacovigilance Safety & Reporting group

Responsibilities (Safety):

  • Perform processing for all types of safety events, medical information call handling activities and other medically related project information.
  • Perform reconciliation of SAEs, literature surveillance, and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.
  • Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
  • Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

For ICON Strategic Solutions, may also include:

  • Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated.
  • Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.
  • Demonstrate skills pertaining to client management, safety reporting, project scope, submission compliance, quality, and budget.
  • Coding Adverse Events in accordance to the applicable standard dictionary
  • Serve as quality complaint processor for assigned projects and monitor the process of returning samples for quality compliant and applicable tracking
  • Complete adverse event and/or product quality complaint cases followup in writing and/or by phone based on requirements for each Client.
  • Perform periodic reconciliation of adverse event and/or quality complaint cases received from different sources within the required deadlines

Responsibilities (Reporting):

  • Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study setup, within project specified timelines.
  • Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures.
  • Maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
  • Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
  • Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
  • Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
  • Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
  • Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
  • Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and thirdparty vendors as applicable. Build and maintain good relationships across functional units.
  • Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases.
  • Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections.
  • Prepare for and represent the department in audits and inspections as designated.
  • Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures,

  • Associate Account Manager

    hace 7 días

    Iztapalapa, Ciudad de México H Code MEXICO A tiempo completo

    :About the Associate Account Manager Role:We are looking for a full-time Associate Account Manager to support the Client Services team and Sales team in meeting campaign objectives and provide a high level of customer service to clients.Requirements:Responsibilities: Own operational processes for assigned accounts in their entirety (managing the kickoff...

  • Sr. Collections Associate

    hace 7 días

    Iztapalapa, Ciudad de México Avantor A tiempo completo

    The Opportunity:The Sr. Collections Associate will work under moderate supervision, obtain revenue by verifying transaction information; compute charges and refunds; prepare and mail invoices; and identify delinquent accounts and insufficient payments. Collect revenue by reminding delinquent accounts; notify customers of insufficient payments. Pay invoices...

  • Quality Assurance Associate

    hace 7 días

    Iztapalapa, Ciudad de México Marken A tiempo completo

    Title:Quality Assurance AssociateJob Purpose:The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies.The QAA I also needs to ensure compliance with applicable regional and local regulations and requirements,...

  • Cloud Support Associate, Aws

    hace 7 días

    Iztapalapa, Ciudad de México Amazon Web Services Mexico S. de R.L. de C.V. A tiempo completo

    6+ months of software development with object oriented language experience 6+ months of scripting language experience 6+ months of network and operating system support experience Bachelor's degree in computer science or equivalent.As a Cloud Support Associate you will learn at an accelerated pace how to use and leverage many different cloud technologies to...

  • Abogado Litigante Especialista en Juicios

    hace 7 días

    Iztapalapa, Ciudad de México Pendulum Associates A tiempo completo

    Únete a la familia Pendulum como:Abogado LitiganteRequisitos: Licenciatura en Derecho Titulado Disponibilidad de litigar en juzgados de CDMX y Estado de México Manejo de al menos 100 juicios de forma simultanea Internet en casa (Esquema híbrido: casacampooficina)Experiência: 2 años en Juicio especial Hipotecario (litigando carteras hipotecarias...

  • Gestor de Cobranza Domiciliar Cdmx

    hace 7 días

    Iztapalapa, Ciudad de México Pendulum Associates A tiempo completo

    Pendulum se encuentra en busca de Gestor de Cobranza DomiciliarRequisitos: Escolaridad: Carrera técnica o Bachillerato concluido con certificado Dominio de Office Se requiere Disponibilidad para viajar y Trabajo en campo 80%- Contar con auto propio para desarrollo de actividades:Contar con licencia y tarjeta de circulación vigente Contar con Internet en...

  • Analista de Tesorería y Cuentas por Cobrar

    hace 7 días

    Iztapalapa, Ciudad de México Pendulum Associates A tiempo completo

    Pendulum se encuentra en busca de tu talento como:Analista de Tesorería y cuentas por CobrarRequisitos: Técnico en contabilidad, Lic. en Contabilidad Pública pasante o trunco (4to semestre) Disponibilidad de horario Internet en casa Manejo ERP contable Portales de banca electrónica (Transferencias electrónicas, dispersión de pagos) Facturación...

  • Associate Partner

    hace 2 meses

    Iztapalapa, Ciudad de México Eaton A tiempo completo

    Eaton's ES GEIS CHD division is currently seeking a Associate Generalist.HR.Business Partner..What You'll DoFUNCION PRINCIPALEjecutar los procesos de Recursos Humanos enfocados a la adquisición de talento, administración de la flota vehicular, mantenimiento de registros y eventos organizacionales acorde con los procesos establecidos por la...

  • Associate Partner

    hace 3 semanas

    Iztapalapa, Ciudad de México Eaton A tiempo completo

    Eaton's ES GEIS CHD division is currently seeking a Associate Generalist.HR.Business Partner..What You'll DoFUNCION PRINCIPALEjecutar los procesos de Recursos Humanos enfocados a la adquisición de talento, administración de la flota vehicular, mantenimiento de registros y eventos organizacionales acorde con los procesos establecidos por la...

  • Associate Partner

    hace 7 días

    Iztapalapa, Ciudad de México Eaton A tiempo completo

    Eaton's ES GEIS CHD division is currently seeking a Associate Generalist.HR.Business Partner.What you'll do:FUNCION PRINCIPALEjecutar los procesos de Recursos Humanos enfocados a la adquisición de talento, administración de la flota vehicular, mantenimiento de registros y eventos organizacionales acorde con los procesos establecidos por la organización.-...

  • Senior Software Engineer

    hace 7 días

    Iztapalapa, Ciudad de México SoftwareOne A tiempo completo

    Job Function:Software & Cloud Services Por qué SoftwareOne?:El éxito en SoftwareOne no se define por lo que haces, sino por lo que entregas a nuestros clientes, al negocio y a los colaboradores que te rodean. Los colaboradores de SoftwareOne están llenos de energía, son ágiles y están enfocados en proporcionar Satisfacción al Cliente y resultados de...

  • Sales Programs Associate Analyst

    hace 7 días

    Iztapalapa, Ciudad de México Salesforce A tiempo completo

    Job CategoryOperationsJob DetailsAbout SalesforceWe're Salesforce, the Customer Company, inspiring the future of business with AI+ Data +CRM. Leading with our core values, we help companies across every industry blaze new trails and connect with customers in a whole new way. And, we empower you to be a Trailblazer, too — driving your performance and career...

  • Customer Service Lead

    hace 7 días

    Iztapalapa, Ciudad de México Avantor A tiempo completo

    The Opportunity:Avantor is looking for a dedicated Customer Service Lead /Líder de Servicio al Cliente. This position is located onsite in Mexico City near The World Trade Center.Supervise customer support team. Responsible for resolving basic to complex customer support issues for customers. Coordinates and leads daily team activities to meet departmental...

  • Service Engineer

    hace 7 días

    Iztapalapa, Ciudad de México ChemTreat A tiempo completo

    Provides technical expertise to sales representatives, resellers and customers during the sales process. Responsible for the development and use of a set of software tools to improve the accuracy, completeness, and timeliness of Quotations, Orders and Order Changes.At Veralto, we value diversity and the existence of similarities and differences, both visible...

  • Business System Support Specialist

    hace 7 días

    Iztapalapa, Ciudad de México Emerson A tiempo completo

    Essential Job Functions: Monitor order queue for new orders and quickly and accurately resolve open inquiries to get orders processed Review and action Oracle sales orders for unorderable parts for hand off to Rapid Repair Center Customer Service Associate for order completion Create and upload serial card references for orders processed Support Diagnostic...

  • Site Manager

    hace 7 días

    Iztapalapa, Ciudad de México EcoLab A tiempo completo

    Lo que te ofrece el cargo:Te unirás a una compañía que ofrece un pago y beneficios competitivos Una trayectoria profesional a largo plazo en el servicio y las ventas Acceso a los programas de capacitación más innovadores de la industria Una cultura que valora la seguridad primero, incluida la capacitación y la protección personal Orgullo de trabajar...

  • Cost Analyst

    hace 7 días

    Iztapalapa, Ciudad de México Bosch Group A tiempo completo

    Company DescriptionFor over a century the name "Bosch" has been associated with forward-looking technology and trailblazing inventions that have made history. Bosch does business all over the world and is active in the most wide-ranging sectors. As a leading supplier in the automotive industry, Robert Bosch is dedicated to improving relationships with our...

  • Customer Business Support Associate- Delivery

    hace 7 días

    Iztapalapa, Ciudad de México SAP A tiempo completo

    We help the world run betterDescriptionPurpose & ObjectivesThe role of the CBS Delivery Operations is to support NA Project Managers in all aspects of the project life cycle including: initiate, plan, execution, monitor and control, and close using our SAP tools and Project Management Methodology. This position is responsible for performing a basic function...

  • Delivery Shift Manager

    hace 6 días

    Iztapalapa, Ciudad de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. A tiempo completo

    Work a flexible schedule/shift/work area, including weekends, nights, and/or holidays A completed Bachelor's Degree or 2+ years Amazon experience. 4+ years of General Experience 2+ Year as People Manager English intermediateadvanced (B2+).At Amazon, we're working to be the most customer-centric company on earth. To get there, we need exceptionally talented,...

  • Customer Relations Process Analyst

    hace 7 días

    Iztapalapa, Ciudad de México The Timken Company A tiempo completo

    Your Career Begins at TimkenIf you're ready for a challenging career that provides you with the ability to advance personally and professionally, look to Timken. Our associates make the world more productive by improving the efficiency and reliability of the machinery that keeps industry in motion.This position will be responsible for continuous process...