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 general 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, local databases, professional society publications and other locally relevant sources.
- Conduct or oversee routine and ad hoc local literature searches and screening in Spanish and Portuguese, and in other relevant local languages, as applicable. Use documented search strategies, product / substance lists, search frequencies, screening criteria and escalation timelines.
- Ensure that local literature screening is appropriately tailored to each market, taking account of country-specific terminology, brand and generic product names, spelling variations, abbreviations, medical terminology and local publication practices.
- Identify potential individual case safety reports (ICSRs), special situations, product quality complaints, medication errors,



lack of efficacy and other reportable safety information in local publications. Ensure prompt triage, follow-up, case processing and reporting within applicable timelines.
- Coordinate accurate translation of potentially relevant literature from Spanish and Portuguese into the agreed working language (e.g., English), including abstracts and full-text articles as needed for medical assessment, case processing and global safety review.
- Ensure that translations are completed by suitably qualified linguists or competent bilingual reviewers with appropriate medical / pharmacovigilance terminology expertise. Oversee translation quality checks and the clarification of ambiguous clinical or safety terminology.
- Assess whether full-text articles need to be retrieved and translated. Document the rationale for relevance and non-relevance decisions, and ensure that source articles, translations, screening outcomes and reviewer decisions are retained in an auditable manner.
- Establish quality-control and oversight measures for local literature screening and translation activities. These should include reviewer training, second-level review where appropriate, reconciliation of screening logs, vendor performance oversight and periodic quality checks.
- Maintain complete, inspection-ready records of literature sources, search dates, search strings, search results, screening decisions, translations, escalations, case references, and any deviations or investigations into missed searches.
- Coordinate with global literature surveillance teams to define interfaces, minimise duplication and prevent gaps between global and local searches, share relevant local sources and findings, and ensure the timely escala

📌 Regional Pharmacovigilance Officer (México)
🏢 Sitero
📍 México