Descripción de la oferta
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 DoingStudy Management & SupportServes as primary Product Safety Lead for assigned studies of moderate to high complexity, operating independently within defined scope and procedural frameworksLeads study-level safety governance, including planning, execution, and oversight of safety data collection, processing, and reporting activitiesDevelops, authors, and maintains study-specific Safety Management Plans, ensuring alignment with protocol requirements, sponsor expectations, and internal procedural documentsActs as the primary Product Safety contact for sponsors and internal project teams; manages day-to-day safety-related communications and issue resolutionChairs or leads study-level safety meetings, prepares content, documents decisions, and tracks action items to completionManages 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 requirementsProvides guidance to Product Safety Specialists and Associates supporting the study, including review of deliverables and escalation of complex issuesSupports proposal development and bid defenses by contributing study-level safety strategy and operational inputConduct preliminary or routine risk assessments to identify potential safety or process risks and elevate findings for review and action by senior/lead team membersParticipates in training and mentoring junior safety team members, helping to develop and deliver training content, providing skill-building support and guidance on best practicesRequirementsBachelor'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 experience2 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 inspectionsExperience 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 codingEffective 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 environmentExercises 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 andby ensuring work products are thorough, reliable, and aligned with broader objectives.#J-18808-Ljbffr
