Associate Director, Pharmacovigilance Country Head - Mexico

About 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 (