Regional Pharmacovigilance Officer (Contract)

Sitero LLC

About The Position

The Regional Pharmacovigilance Officer works with cross-functional teams to oversee pharmacovigilance activities and support compliance with country-specific requirements across Latin America. The role focuses particularly on establishing and overseeing a robust, documented local medical literature surveillance process across relevant LATAM markets, including Spanish- and Portuguese-language sources. It also supports local safety oversight, regulatory interactions, signal and risk management, and alignment of local activities with the global pharmacovigilance system. The officer oversees local literature source identification, searches, screening, translation, assessment, escalation, and traceable documentation. The role coordinates with global literature surveillance teams and local stakeholders, supports safety case handling and reporting, and contributes to audit readiness, inspections, quality oversight, and continuous improvement.

Requirements

A degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences, or an equivalent healthcare or scientific discipline.
Relevant pharmaceutical industry experience and demonstrated competence in pharmacovigilance.
At least 3 years of relevant pharmacovigilance, medical, scientific/clinical, pharmaceutical, or regulatory experience.
Working proficiency in Spanish and/or Portuguese, depending on assigned markets.
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 programs, 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.
Ability to assess the clinical meaning of local-language publications and accurately convey medical concepts, idiomatic expressions, local product names, and country-specific terminology to global PV teams.
Knowledge of LATAM regulatory and pharmacovigilance environments and local reporting expectations.
Good working knowledge of GVP principles and global pharmacovigilance requirements, with the ability to 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.
Experience working 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 or databases, and ability to maintain accurate screening logs and traceable records.
Strong written and verbal communication skills for working with Spanish- and/or Portuguese-speaking stakeholders and English-speaking global teams.
Excellent organizational skills, attention to detail, cultural awareness, and ability to manage multiple country requirements, timelines, and priorities.

Nice To Haves

A master’s or doctoral degree in a relevant discipline.
Experience supporting LATAM markets.
Professional fluency in both Spanish and Portuguese for regional coverage.
Proficiency in additional relevant local languages.

Responsibilities

Act as the Regional PV Officer for assigned LATAM countries and perform applicable local PV responsibilities where formally appointed or required.
Oversee day-to-day pharmacovigilance activities across assigned LATAM markets, ensuring compliance with national legislation, health authority requirements, local procedures, and global PV policies.
Maintain current knowledge of country-specific PV requirements and regulatory expectations across LATAM.
Develop, implement, and maintain country-level local medical literature surveillance plans and inventories of relevant sources.
Conduct or oversee routine and ad hoc literature searches and screening in Spanish, Portuguese, and other applicable local languages using documented strategies, criteria, frequencies, and escalation timelines.
Tailor local literature screening to country-specific terminology, product names, spelling variations, abbreviations, medical terminology, and publication practices.
Identify potential individual case safety reports, 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 relevant literature into the agreed working language, oversee translation quality checks, and clarify ambiguous clinical or safety terminology.
Assess whether full-text articles need to be retrieved and translated, document relevance decisions, and retain source articles, translations, screening outcomes, and reviewer decisions in an auditable manner.
Establish quality-control and oversight measures for literature screening and translation, including training, second-level review where appropriate, log reconciliation, vendor oversight, and periodic checks.
Maintain complete, inspection-ready records of sources, searches, results, screening decisions, translations, escalations, case references, and deviations or investigations into missed searches.
Coordinate with global literature surveillance teams to define interfaces, minimize duplication, prevent gaps, share local sources and findings, and escalate significant safety information.
Support signal detection and evaluation by providing relevant publications and local medical, clinical, epidemiological, treatment, and practice context.
Support local inspection and audit readiness and participate in audits, inspections, and local PV system reviews.
Contribute to continuous improvement, root-cause analysis, and corrective and preventive actions where applicable.
Remain contactable during agreed business hours and support timely escalation of urgent safety matters across assigned LATAM time zones.
Foster collaboration among country teams, global PV functions, medical and regulatory colleagues, and external service providers.