Regional Pharmacovigilance Officer – Contract

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🇲🇽 Mexico – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Sitero

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

⚕️ Healthcare Insurance

Healthcare • Consulting • Healthcare Insurance

Sitero is a next-generation clinical trial solutions provider that accelerates clinical trials, ensures compliance and safety, and enables innovation through advanced technology and world-class services. They offer a wide range of clinical services, including site support and activation, data management, biostatistics, and drug safety. Sitero specializes in eClinical technology, providing end-to-end, technology-enabled services such as electronic data capture, randomization and trial supply management, clinical trial management systems, electronic consent solutions, and payment systems. Their services also include IRB ethical review, biosafety consulting, and pharmacovigilance agreements, ensuring comprehensive support for clinical research organizations.

📋 Description

• 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 • Maintain current knowledge of country-specific PV requirements and regulatory expectations • Develop, implement and maintain country-level local medical literature surveillance plans • Identify and assess local literature sources, including journals, medical publications, academic repositories, databases and professional society publications • Conduct or oversee routine and ad hoc literature searches and screening in Spanish, Portuguese and other relevant local languages • Use documented search strategies, product/substance lists, search frequencies, screening criteria and escalation timelines • Identify potential ICSRs, special situations, product quality complaints, medication errors, lack of efficacy and other reportable safety information • Coordinate translation of relevant literature into the agreed working language • Oversee translation quality checks and clarification of ambiguous clinical or safety terminology • Assess full-text retrieval and translation needs and document relevance decisions • Establish quality-control and oversight measures for literature screening and translation activities • Maintain inspection-ready records of literature sources, searches, screening decisions, translations, escalations, case references and deviations • Coordinate with global literature surveillance teams to minimize duplication and prevent gaps • Support signal detection and evaluation with relevant publications and local medical, clinical, epidemiological and treatment context • Support local inspection and audit readiness • Assist with audits, inspections and local PV system reviews • Contribute to root-cause analysis, CAPAs and continuous improvement initiatives • Remain contactable during agreed business hours and support urgent safety escalations across assigned LATAM time zones • Foster collaboration across country teams, global PV functions, medical/regulatory colleagues and external service providers

🎯 Requirements

• 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 • 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 Spanish and Portuguese is strongly preferred for regional coverage • Proficiency in additional relevant local languages is an advantage • Ability to screen and interpret medical and scientific literature in Spanish and/or Portuguese • Experience designing or managing local literature surveillance programmes • Strong medical/scientific translation and interpretation skills, or experience managing qualified translation resources • Knowledge of LATAM regulatory and PV environments • Good working knowledge of GVP principles and global pharmacovigilance requirements • Experience 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 • Knowledge of MedDRA, safety database systems and relevant literature search tools/databases • Strong written and verbal communication skills 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 • Availability during agreed business hours, with flexibility to support relevant LATAM time zones and urgent safety escalations

🏖️ Benefits

• Competitive salary • Variable pay • Paid time off • Healthcare benefits • Retirement benefits

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