Associate Director, Pharmacovigilance Country Head – Mexico

Moderna • Cambridge, MA

29d

About The Position

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.

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.

Requirements

• Fluent in Spanish; professional proficiency in English required.

Nice To Haves

• 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.

Responsibilities

• 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.
• Act 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees