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Senior Safety Specialist

En remoto desde España·Añadida hoy (comprobada el 6 nov)

Rho Inc

3 ofertas abiertas

Nuestro resumen

Modalidad
En remoto desde España
Inglés
Obligatorio

Habilidades

Se valora

Esta oferta está publicada en inglés.

El puesto

Join us in redefining what it means to work for a CRO.

When you work at Rho, it's more than just a job-you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work-and each other.

You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

This is your opportunity to join Rho as a Senior Safety Specialist - we are open to this role being located in Poland, UK, or Spain. This is a remote opportunity.

Product Safety Team professionals are integral for the case management of federally and commercially funded clinical studies. While ensuring adherence to study protocols and internal SOPS, this team prepares safety-related documentation, oversees day-to-day activities, manages end-to-end case processing, and collaborates with internal and external stakeholders.

What You Will Be Doing

Study Management & Support

  • Serves as primary Product Safety Lead for assigned studies of moderate to high complexity, operating independently within defined scope and procedural frameworks
  • Leads study-level safety governance, including planning, execution, and oversight of safety data collection, processing, and reporting activities
  • Develops, authors, and maintains study-specific Safety Management Plans, ensuring alignment with protocol requirements, sponsor expectations, and internal procedural documents
  • Acts as the primary Product Safety contact for sponsors and internal project teams; manages day-to-day safety-related communications and issue resolution
  • Chairs or leads study-level safety meetings, prepares content, documents decisions, and tracks action items to completion
  • Manages study-level safety scope, timelines, and budgets; identifies and escalates risks that may impact deliverables, quality, or compliance Oversees safety start-up and close-out activities, ensuring inspection-ready documentation and adherence to internal SOPs and project-specific requirements
  • Provides guidance to Product Safety Specialists and Associates supporting the study, including review of deliverables and escalation of complex issues
  • Supports proposal development and bid defenses by contributing study-level safety strategy and operational input
  • Conduct preliminary or routine risk assessments to identify potential safety or process risks and escalate findings for review and action by senior/lead team members
  • Participates in training and mentoring junior safety team members, helping to develop and deliver training content, providing skill-building support and guidance on best practices

Requirements

  • Bachelor's degree (e.g., RN, Health Sciences, PharmD) or equivalent combination of education and relevant product safety or clinical research experience along with 5+ years of product safety/pharmacovigilance experience
  • 2 years of experience working as a Product Safety Lead on Clinical Trials is required, including developing Safety Management Plans and site training materials and supporting inspections
  • Experience with Argus is preferred; proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.)
  • Strong knowledge of safety data collection, processing and reporting requirements; strong knowledge of global regulatory requirements for pharmacovigilance; advanced knowledge of safety database applications and MedDRA/WHO Drug coding
  • Effective verbal and written communication and presentation skills with proficiency in both English and local language, with the ability to convey complex or nuanced information clearly across diverse audiences.
  • Ability to work effectively and collaboratively within a team environment
  • Exercises strong judgment in complex or ambiguous situations by weighing risks, considering multiple perspectives, and making decisions that balance accuracy, timeliness, and broader implications.
  • Exhibits advanced detail orientation by proactively identifying issues, inconsistencies, or risks and
  • by ensuring work products are thorough, reliable, and aligned with broader objectives.

Sobre Rho Inc

Rho Inc. es una organización global de investigación por contrato (CRO) especializada en la gestión de ensayos clínicos y consultoría bioestadística para las industrias farmacéutica y biotecnológica. Con una plantilla de más de 1.000 profesionales, Rho ofrece una amplia gama de servicios que incluyen gestión de datos, bioestadística, monitorización clínica y farmacovigilancia, apoyando el desarrollo de fármacos desde los estudios de fase inicial hasta la vigilancia posterior a la comercialización.

Rho ha establecido una presencia significativa en España, con oficinas en Barcelona y Madrid que sirven como centros clave para sus operaciones europeas. La empresa es conocida por su cultura colaborativa y orientada a la ciencia, y recluta activamente talento internacional, ofreciendo una vía para que profesionales experimentados en investigación clínica trabajen en estudios globales desde España.

Fundación
1982
Plantilla
1,000–5,000
Sede
Durham, EE. UU.
En España
Barcelona

Datos prácticos

  • Rho ofrece patrocinio de visados y apoyo para la reubicación de contrataciones internacionales, facilitando la transición a España.
  • El trabajo en la empresa se realiza en inglés, lo que la hace accesible para quienes no hablan español.
  • Barcelona es un importante centro europeo con excelente conectividad internacional y una gran comunidad de expatriados.
  • Rho ofrece desarrollo profesional estructurado y formación en metodologías de investigación clínica.
  • La empresa tiene una cultura plana y colaborativa donde se valora la experiencia científica por encima de la jerarquía corporativa.
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