R

Rho

Comprehensive CRO for regulatory drug approvals

Senior Safety Specialist

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A bachelor's degree, such as in nursing, health sciences, or pharmacy, or an equivalent combination of education and relevant product safety or clinical research experience, along with at least five years of product safety or pharmacovigilance experience.
  • At least two years of experience as a Product Safety Lead on clinical trials, including developing Safety Management Plans and site training materials and supporting inspections.
  • Proficiency with business productivity software such as Excel, Word, and PowerPoint.
  • 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 and WHO Drug coding.
  • Proficiency in English and the local language, with effective verbal, written, and presentation skills and the ability to communicate complex or nuanced information clearly across diverse audiences.
  • Ability to work effectively and collaboratively within a team environment.
  • Strong judgment in complex or ambiguous situations, weighing risks and perspectives and making decisions that balance accuracy, timeliness, and broader implications.
  • Advanced attention to detail, including proactively identifying issues, inconsistencies, or risks and ensuring work products are thorough, reliable, and aligned with broader objectives.

Responsibilities

  • Serve independently within defined scope and procedural frameworks as the primary Product Safety Lead for assigned studies of moderate to high complexity.
  • Lead study-level safety governance, including planning, execution, and oversight of safety data collection, processing, and reporting activities.
  • Develop, author, and maintain study-specific Safety Management Plans aligned with protocol requirements, sponsor expectations, and internal procedural documents.
  • Act as the primary Product Safety contact for sponsors and internal project teams, managing day-to-day safety communications and issue resolution.
  • Lead study-level safety meetings, prepare content, document decisions, and track action items to completion.
  • Manage study-level safety scope, timelines, and budgets; identify and escalate risks that may affect deliverables, quality, or compliance.
  • Oversee safety start-up and close-out activities, ensuring inspection-ready documentation and adherence to internal standard operating procedures and project-specific requirements.
  • Guide Product Safety Specialists and Associates supporting the study, including reviewing deliverables and escalating complex issues.
  • Support 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 or lead team members.
  • Participate in training and mentoring junior safety team members, help develop and deliver training content, and provide skill-building support and guidance on best practices.

Desired Qualifications

  • Experience with Argus.

About the Company

Rho

Comprehensive CRO for regulatory drug approvals

Rho is a contract research organization that provides end-to-end services for developing and gaining regulatory approval for drugs, biologics, and medical devices. It supports planning and executing clinical development, regulatory strategy, and marketing submissions, guiding projects from program strategy through NDAs, BLAs, and MAAs. An integrated team handles decentralized clinical trials and has infectious-disease programs, combining trial design, data management, and regulatory insight to move products toward approval. Its goal is to help clients bring products to market efficiently by navigating regulatory requirements and streamlining development and submission processes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Durham, NC
Founded
1984

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