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, 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 escalation of potentially significant safety information.
• Support signal detection and evaluation by providing relevant publications, local medical and clinical context, country-specific epidemiological and treatment information, and insights into local clinical practice, as appropriate.
• Support local inspection and audit readiness, including availability of literature surveillance evidence, translation records, screening logs, training records and documented oversight of outsourced activities.
• Assist with and participate in audits, inspections and local PV system reviews. Contribute to continuous improvement initiatives, including root-cause analysis and the implementation of corrective and preventive actions (CAPAs), where applicable.
• Remain contactable during agreed business hours and support timely escalation of urgent safety matters across assigned LATAM time zones.
• Foster collaboration across country teams, global PV functions, medical / regulatory colleagues and external service providers, promoting consistency, quality and continuous improvement.

EDUCATION AND EXPERIENCE REQUIRED:

• A degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or an equivalent healthcare or scientific discipline, together with relevant pharmaceutical industry experience and demonstrated competence in pharmacovigilance.
• A master’s or doctoral degree in a relevant discipline is preferred.

PREFERRED SKILLS:

• At least 3 years of relevant pharmacovigilance, medical, scientific / clinical, pharmaceutical or regulatory experience; experience supporting LATAM markets is strongly preferred.
• Working proficiency in Spanish and/or Portuguese is essential, depending on the assigned markets. Professional fluency in both languages is strongly preferred for regional coverage; proficiency in additional relevant local languages is an advantage.
• Demonstrated ability to screen and interpret medical and scientific literature in Spanish and / or Portuguese, including recognition of potential adverse events, individual case safety reports, special situations and emerging safety concerns.
• Experience designing or managing local literature surveillance programmes, including source mapping, search strategy development, search frequency setting, screening criteria, documentation, quality control and audit trail maintenance.
• Strong medical / scientific translation and interpretation skills, or experience managing qualified translation resources, to ensure the accurate translation of safety-relevant publications into the agreed global working language.
• Ability to assess the clinical meaning of local-language publications and translate medical concepts, idiomatic expressions, local product names and country-specific terminology into clear, accurate safety information for global PV teams.
• Knowledge of LATAM regulatory and PV environments, including familiarity with national health authority requirements and local reporting expectations in key markets such as Brazil, Mexico, Argentina, Colombia and Peru, as well as Chile.
• Good working knowledge of GVP principles and global pharmacovigilance requirements, with the ability to interpret and apply country-specific requirements in a regional operating model.
• Experience reviewing safety information from multiple sources and supporting ICSR intake, case processing, follow-up, regulatory reporting, signal management and risk management activities.
• Experience with local affiliates, distributors, license partners, literature vendors, translation providers and other outsourced service providers, including vendor oversight and performance monitoring.
• Knowledge of MedDRA, safety database systems and relevant literature search tools / databases; ability to maintain accurate screening logs and traceable records.
• Strong written and verbal communication skills, with the ability to communicate effectively across Spanish- / Portuguese-speaking local stakeholders and English-speaking global teams.
• Excellent organizational skills, attention to detail, cultural awareness and ability to manage multiple country requirements, timelines and priorities.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Contractual, on an as-needed basis.

COMMITMENTS:

• Availability during agreed business hours, with flexibility to support relevant LATAM time zones and urgent safety escalations.

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Originally posted on Himalayas