Regional Pharmacovigilance Officer (Contract)

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Regional PV Officer Location: Mexico Function: Drug Safety DESCRIPTION: The Regional PV Officer works collaboratively with cross-functional teams to oversee pharmacovigilance activities and support compliance with applicable country-specific requirements across Latin America. The role has a particular focus on establishing and overseeing a robust, documented local medical literature surveillance process across relevant LATAM markets, including Spanish- and Portuguese-language sources. Responsibilities include identifying and assessing local literature sources; coordinating the screening and translation of potentially relevant publications; ensuring the timely identification and escalation of safety information; and maintaining traceable records of search, screening, translation and review activities. The role also supports local safety oversight, regulatory interactions, signal and risk management, and alignment of local activities with the global pharmacovigilance system. ESSENTIAL DUTIES AND RESPONSIBILITIES: Act as the Regional PV Officer for assigned LATAM countries and, where formally appointed or required, perform the applicable local PV responsibilities. Oversee day-to-day pharmacovigilance activities across assigned LATAM markets, ensuring compliance with applicable national legislation, health authority requirements, local procedures and Sitero / client global PV policies. Maintain up-to-date knowledge of country-specific PV requirements and regulatory expectations across LATAM, including, as applicable, requirements issued by ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), ANMAT (Argentina), ISP (Chile), DIGEMID (Peru) and other relevant national authorities. Develop, implement and maintain a country-level local medical literature surveillance plan for assigned LATAM markets, with a defined inventory of relevant national and regional journals, medical publications, academic repositories,...

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