Safety & PV Specialist

This role supports critical pharmacovigilance and safety activities across clinical development and post-marketing programs. Local São Paulo - SP Remoto

Responsabilidades

Enter and track safety information in pharmacovigilance quality and tracking systems, supporting the processing of ICSRs according to applicable SOPs, project-specific safety plans, and regulatory requirements. Triage ICSRs and evaluate case information for completeness, accuracy, and regulatory reportability. Code adverse events, medical history, concomitant medications, tests, and other relevant information using applicable medical coding standards and terminology.

Prepare complete and accurate narrative summaries, identify missing or unclear information, and manage follow-up queries until the required information is obtained and satisfactorily resolved. Support the timely, consistent, and accurate generation and submission of expedited safety reports in accordance with applicable regulatory requirements. Perform literature screening and review activities related to safety, including drug coding and maintenance of relevant drug dictionaries.

Validate and submit xEVMPD product records, including appropriate indication coding using MedDRA, and manually recode unrecognized or incorrectly coded product and substance terms when required. Identify and manage duplicate ICSRs to maintain the integrity and accuracy of pharmacovigilance databases. Support activities related to SPOR and IDMP data standards and requirements. Conduct quality reviews of ICSRs and contribute to maintaining high standards of case-processing accuracy and compliance.

Ensure relevant documentation is appropriately filed in the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File for post-marketing programs, in line with applicable requirements. Maintain knowledge of SOPs, work instructions, global drug, biologic and device regulations, GCP, ICH guidelines, GVP, project plans, and the broader drug development process, applying relevant regulatory intelligence to safety activities.

Build constructive working relationships with internal and external project teams and participate in audits when required.

Requisitos

Bachelor's degree in a life-science discipline, or qualification as a registered nurse, pharmacist, or equivalent combination of education and experience providing the required knowledge and capabilities. Practical knowledge of safety database systems and medical terminology, with an understanding of pharmacovigilance processes and safety reporting requirements.

Good understanding of clinical trial processes across Phases II–IV and/or post-marketing safety requirements, including ICH GCP, GVP, and relevant safety and pharmacovigilance regulations. Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint, as well as Visio, Outlook, shared workspace/content-management platforms, and internet-based tools. Strong attention to detail, accuracy, and ability to identify inconsistencies or missing information in safety data and documentation.

Strong organizational and prioritization skills, with the ability to manage multiple tasks and projects while consistently meeting deadlines. Excellent written and verbal communication and interpersonal skills, with the ability to collaborate effectively across different teams and stakeholders. Ability to work independently while also contributing effectively within multidisciplinary and international project teams.

Commitment to following established procedures, regulatory standards, and quality requirements in all pharmacovigilance activities.

Benefícios

Fully remote opportunity within Brazil, under the applicable pre-approved remote work arrangement. Opportunities for career development and progression within a global life-sciences environment. Access to technical and therapeutic-area training to strengthen pharmacovigilance and industry expertise. Engaged line management and collaboration with experienced professionals across specialized teams. Access to peer recognition initiatives and a total rewards program.

Opportunity to work with multidisciplinary teams and international stakeholders across clinical development and pharmacovigilance programs. Exposure to diverse projects, therapeutic areas, technologies, and professional development opportunities. A collaborative environment designed to encourage different perspectives, professional growth, and meaningful contributions. Opportunity to contribute to safety activities supporting the development and monitoring of therapies that can improve patients' lives.

Sobre A Empresa: This position is listed on behalf of a partner company, who manages all applications and next steps.