*el puesto:*el/la associate director, pharmacovigilance country head – méxico es responsable de liderar y supervisar todas las actividades de farmacovigilancia en méxico, garantizando el pleno cumplimiento de los requisitos regulatorios locales aplicables.
este puesto coordinará todas las actividades necesarias en méxico para asegurar un alto estándar de operación en farmacovigilancia.
este rol actúa como responsable local de pv y principal punto de contacto para las autoridades regulatorias, socios comerciales, proveedores de servicios y partes interesadas internas, asegurando la alineación con las estrategias regionales y globales de farmacovigilancia.
este puesto apoyará la estrategia de farmacovigilancia en latam.
*esto es lo que aportarás:*• proporcionar liderazgo estratégico y supervisión de todas las actividades de farmacovigilancia en méxico.
• asegurar el cumplimiento de todas las obligaciones locales de reporte en pv, incluyendo la presentación de icsr, informes agregados de seguridad (psur/pbrer) y requisitos de rmp.
• actuar como el principal punto de contacto en farmacovigilancia para cofepris y otras autoridades regulatorias mexicanas relevantes.
• supervisar a los proveedores locales de pv y prestadores de servicios que realizan actividades en nombre de la empresa.
• garantizar la implementación y el mantenimiento del sistema local de pv alineado con los procesos globales de farmacovigilancia y los sistemas de gestión de calidad (qms).
• liderar las actividades de preparación para inspecciones y participar activamente en inspecciones regulatorias, auditorías de socios y auditorías internas.
• asegurar prácticas adecuadas de documentación en cumplimiento con los principios gxp y las regulaciones locales.
• supervisar la implementación y el seguimiento de los planes de gestión de riesgos (rmp), incluyendo actividades adicionales de pv y minimización de riesgos según sea necesario.
• monitorear las tendencias locales de datos de seguridad y asegurar su adecuada escalada a los equipos regionales y globales de seguridad.
• mantener planes de continuidad del negocio para las operaciones de pv en méxico.
• colaborar de manera transversal con los equipos de regulatory affairs, medical affairs, calidad, legal y comercial.
• apoyar las iniciativas regionales de latam y la supervisión de pv.
*esto es lo que aportarás (cualificaciones preferidas):*• título universitario en ciencias de la salud requerido; se prefiere un máster.
• mínimo 10 años de experiencia en farmacovigilancia, incluyendo 4 años en roles de liderazgo en méxico.
• sólido conocimiento de la normativa mexicana de farmacovigilancia (nom-220-ssa*) y los requisitos de cofepris.
• experiencia demostrada en la gestión de casos icsr, reportes agregados, gestión de rmp y supervisión del qms de pv.
• experiencia interactuando directamente con autoridades regulatorias en méxico.
• experiencia en la gestión de proveedores y prestadores de servicios externos.
• experiencia en gestión de inspecciones y auditorías.
• fuertes habilidades analíticas, pensamiento estratégico y toma de decisiones.
• capacidad para operar eficazmente en un entorno regulatorio dinámico y en constante evolución.
• excelentes habilidades de comunicación y gestión de stakeholders.
• fluidez en español; se requiere dominio profesional del inglés.
*the role:*the associate director, pharmacovigilance country head – mexico is responsible for leading and overseeing all pharmacovigilance activities within mexico, ensuring full compliance with local applicable regulatory requirements.
this role will coordinate all activities required in mexico to ensure a high standard pharmacovigilance operation.
this role serves as the local pv head and primary point of contact for regulatory authorities, business partners, service providers and internal stakeholders, ensuring alignment with regional and global pharmacovigilance strategies.
this role will support the pharmacovigilance strategy in latam.
*here's what you'll bring to the table:* provide strategic leadership and oversight of all pharmacovigilance activities in mexico.
* ensure compliance with all local pv reporting obligations, including icsr submissions, aggregate safety reports (psur/pbrer), and rmp requirements.
* serve as the primary pharmacovigilance contact for cofepris and other relevant mexican regulatory authorities.
* oversee local pv vendors and service providers performing activities on behalf of the company.
* ensure implementation and maintenance of the local pv system aligned with global pv processes and quality management systems (qms).
* lead inspection readiness activities and actively participate in regulatory inspections, partner audits, and internal audits.
* ensure proper documentation practices in compliance with gxp principles and local regulations.
* oversee implementation and monitoring of risk management plans (rmps), including additional pv and risk minimization activities as required.
* monitor local safety data trends and ensure appropriate escalation to regional and global safety leadership.
* maintain business continuity plans for pv operations in mexico.
* collaborate cross-functionally with regulatory affairs, medical affairs, quality, legal, and commercial teams.
* support latam regional initiatives and pv oversight.
*here's what you'll bring to the table (preferred qualifications):* bachelor's degree in a health sciences field is required; a master's degree is preferred.
* minimum 10 years of experience in pharmacovigilance, including 4 years in leadership roles in mexico.
* strong knowledge of mexican pharmacovigilance regulations (nom-220-ssa*) and cofepris requirements.
* demonstrated experience in icsr case management, aggregate reporting, rmp management, and pv qms oversight.
* experience interacting directly with regulatory authorities in mexico.
* experience managing vendors and third-party service providers.
* experience in inspection and audit management.
* strong analytical, strategic thinking, and decision-making skills.
* ability to operate effectively in a fast-paced and evolving regulatory environment.
* excellent communication and stakeholder management skills.
* fluent in spanish; professional proficiency in english required.
*pay & benefits*at moderna, we believe that when you feel your best, you can do your best work.
that's why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
* a holistic approach to well-being with access to fitness, mindfulness, and mental health support* family building benefits, including fertility, adoption, and surrogacy support* generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownthe benefits offered may vary depending on the nature of your employment with moderna and the country where you work.
*about moderna*since our founding in *, we have aspired to build the leading mrna technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
we believe in giving our people a platform to change medicine and an opportunity to change the world.by living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.we are proud to have been recognized as a science magazine top biopharma employer, a fast company best workplace for innovators, and a great place to work in the u.s.as we build our company, we have always believed an in-person culture is critical to our success.
moderna champions the significant benefits of in-office collaboration by embracing a
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