Associate Director, Pharmacovigilance Country Head – Mexico

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-SSA1-2016) 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 shutdown

The 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 2010, 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 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. 

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Pago y beneficios

En Moderna, creemos que cuando te sientes en tu mejor momento, puedes dar lo mejor de ti. Por eso, nuestros beneficios globales y recursos de bienestar están diseñados para apoyarte — en el trabajo, en casa y en todos los aspectos de tu vida.

• Un enfoque integral del bienestar, con acceso a apoyo en actividad física, mindfulness y salud mental.

• Beneficios para la formación de familia, incluyendo apoyo para tratamientos de fertilidad, adopción y gestación subrogada.

• Generoso tiempo libre retribuido, que incluye vacaciones, festivos, días de voluntariado, año sabático, días globales de recarga y un cierre discrecional a final de año.

Los beneficios ofrecidos pueden variar en función de la naturaleza de tu relación laboral con Moderna y del país en el que trabajes.

Acerca de Moderna

Desde nuestra fundación en 2010, hemos aspirado a construir la principal plataforma de tecnología de ARNm, la infraestructura necesaria para reinventar la forma en que se crean y administran los medicamentos, y un equipo de primer nivel a escala mundial. Creemos en ofrecer a nuestra gente una plataforma para transformar la medicina y una oportunidad real de cambiar el mundo.

Viviendo cada día nuestra misión, valores y mentalidades, nuestras personas son la fuerza impulsora de nuestro progreso científico y de nuestra cultura. Juntos, estamos creando una cultura inclusiva y construyendo una organización que se preocupa profundamente por nuestros pacientes, nuestros empleados, el medio ambiente y nuestras comunidades.

Nos enorgullece haber sido reconocidos como uno de los Mejores Empleadores en Biociencias por Science Magazine, uno de los Best Workplaces for Innovators por Fast Company y como Great Place to Work en Estados Unidos.

A medida que seguimos desarrollando nuestra empresa, hemos mantenido la convicción de que una cultura presencial es fundamental para nuestro éxito. Moderna promueve los beneficios clave de la colaboración en oficina mediante un modelo de trabajo 70/30. Esta estructura —70 % presencial— fomenta una cultura rica en innovación, trabajo en equipo y mentoría directa. Únete a nosotros para dar forma a un mundo donde cada interacción sea una oportunidad para aprender, contribuir y generar un impacto significativo.

Si quieres marcar la diferencia y formar parte de un equipo que está transformando el futuro de la medicina, te invitamos a visitar modernatx.com/careers para conocer nuestras vacantes actuales.

Moderna es un entorno libre de humo, alcohol y drogas.

Moderna es un lugar donde todas las personas pueden crecer. Si cumples con los requisitos básicos del puesto y te entusiasma contribuir a nuestra misión cada día, te animamos a presentar tu candidatura.

Moderna está comprometida con la igualdad de oportunidades y la no discriminación para todos los empleados y candidatos cualificados, sin distinción de raza, color, sexo, identidad o expresión de género, edad, religión, origen nacional, ascendencia o ciudadanía, etnia, discapacidad, condición militar o de veterano protegido, información genética, orientación sexual, estado civil o situación familiar, o cualquier otra característica protegida por la legislación aplicable. Consideramos a los candidatos cualificados independientemente de sus antecedentes penales, conforme a los requisitos legales.

Nos centramos en atraer, retener, desarrollar y promocionar a nuestras personas. Al fomentar un entorno laboral que valora experiencias, trayectorias e ideas diversas, creamos un espacio donde cada persona puede aportar lo mejor de sí misma.

Moderna se compromete a proporcionar ajustes razonables a candidatos con discapacidad. Cualquier persona que necesite una adaptación durante el proceso de selección o para desempeñar las funciones esenciales del puesto al que opta puede ponerse en contacto con el equipo de Accommodations and Adjustments en leavesandaccommodations@modernatx.com.

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