Senior Safety Specialist

🔥 15 hours ago

🌐 Poland, United Kingdom, +1 more countries – Remote

🇵🇱 Poland – Remote 🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Rho

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1984

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Rho is a financial technology company that provides integrated banking solutions for businesses, combining modern banking with cash management and expense tracking. Their platform focuses on streamlining financial operations and offering a user-friendly interface for better control of company finances.

📋 Description

• Serve as primary Product Safety Lead for assigned moderate- to high-complexity studies • Lead study-level safety governance, including planning, execution, and oversight of safety data collection, processing, and reporting • Develop, author, and maintain study-specific Safety Management Plans • Act as primary Product Safety contact for sponsors and internal project teams • Manage safety-related communications and issue resolution • Lead study-level safety meetings, document decisions, and track action items • Manage study-level safety scope, timelines, and budgets • Identify and escalate risks affecting deliverables, quality, or compliance • Oversee safety start-up and close-out activities and maintain inspection-ready documentation • Guide Product Safety Specialists and Associates, including reviewing deliverables and escalating complex issues • Support proposal development and bid defenses with study-level safety strategy and operational input • Conduct preliminary or routine risk assessments • Participate in training and mentoring junior safety team members

🎯 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 • Proficiency in both English and local language • Effective verbal and written communication and presentation skills • Ability to work effectively and collaboratively within a team environment • Strong judgment in complex or ambiguous situations • Advanced attention to detail, including identifying issues, inconsistencies, or risks and ensuring work products are thorough and reliable

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