Regional Pharmacovigilance Officer – Contract

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Serve as the Regional PV Officer for designated LATAM countries and fulfill local PV responsibilities as needed or formally designated.

• Supervise daily pharmacovigilance operations within assigned LATAM markets.

• Stay informed about country-specific PV regulations and regulatory expectations.

• Create, implement, and uphold local medical literature surveillance plans at the country level.

• Identify and evaluate local literature sources, including journals, medical publications, academic repositories, databases, and publications from professional societies.

• Conduct or supervise regular and ad hoc literature searches and screenings in Spanish, Portuguese, and other pertinent local languages.

• Utilize documented search strategies, product/substance lists, search frequencies, screening criteria, and escalation timelines.

• Identify potential Individual Case Safety Reports (ICSRs), special situations, product quality complaints, medication errors, lack of efficacy, and other reportable safety information.

• Manage the translation of pertinent literature into the designated working language.

• Ensure the quality of translations and clarify any ambiguous clinical or safety terminology.

• Assess the needs for full-text retrieval and translation, documenting relevance decisions.

• Establish quality control and oversight measures for literature screening and translation tasks.

• Maintain inspection-ready documentation of literature sources, searches, screening decisions, translations, escalations, case references, and deviations.

• Collaborate with global literature surveillance teams to reduce duplication and close any gaps.

• Assist in signal detection and evaluation with relevant publications, considering local medical, clinical, epidemiological, and treatment contexts.

• Support local inspection and audit readiness.

• Aid in audits, inspections, and local PV system assessments.

• Participate in root cause analysis, Corrective and Preventive Actions (CAPAs), and continuous improvement initiatives.

• Be available during agreed business hours and assist with urgent safety escalations across assigned LATAM time zones.

• Promote collaboration among country teams, global PV functions, medical/regulatory colleagues, and external service providers.

⛳️ Requirements

• A degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences, or a similar healthcare or scientific field, along with relevant experience in the pharmaceutical industry and proven competence in pharmacovigilance.

• A minimum of 3 years of relevant experience in pharmacovigilance, medical, scientific/clinical, pharmaceutical, or regulatory roles.

• Experience supporting LATAM markets is highly desirable.

• Proficiency in Spanish and/or Portuguese is crucial, depending on the assigned markets.

• Professional fluency in both Spanish and Portuguese is strongly preferred for regional coverage.

• Knowledge of additional relevant local languages is advantageous.

• Ability to screen and interpret medical and scientific literature in Spanish and/or Portuguese.

• Experience in designing or managing local literature surveillance programs.

• Strong medical/scientific translation and interpretation skills, or experience overseeing qualified translation resources.

• Familiarity with LATAM regulatory and PV frameworks.

• Solid understanding of Good Vigilance Practice (GVP) principles and global pharmacovigilance requirements.

• Experience in supporting ICSR intake, case processing, follow-up, regulatory reporting, signal management, and risk management activities.

• Experience working with local affiliates, distributors, license partners, literature vendors, translation service providers, and other outsourced service providers.

• Knowledge of MedDRA, safety database systems, and relevant literature search tools/databases.

• Excellent written and verbal communication skills with Spanish-/Portuguese-speaking local stakeholders and English-speaking global teams.

• Strong organizational skills, attention to detail, cultural sensitivity, and the ability to manage multiple country requirements, timelines, and priorities.

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

🏝️ Benefits

• Competitive salary

• Variable pay

• Paid time off

• Healthcare benefits

• Retirement benefits