Senior Product Safety Lead, Clinical Trials (Remote)

RHO Inc; España; Remote; EUR 70,000 - 95,000; Full time

Job summary

RHO Inc is seeking a Senior Safety Specialist to join its Product Safety Team. The role is remote and open to candidates in Poland, the UK, or Spain. You will oversee study safety governance, develop safety plans, and act as the primary contact for sponsors and internal teams.

You will lead safety data collection, reporting, and compliance with global pharmacovigilance regulations, while mentoring junior staff and supporting training. Fluency in English and local language is required.

Qualifications

• Bachelor’s degree in health sciences or related field with 5+ years of product safety/pharmacovigilance experience.
• 2+ years as Product Safety Lead on Clinical Trials, developing Safety Management Plans and supporting inspections.
• Experience with Argus; proficient in Excel, Word, and PowerPoint.
• Strong knowledge of safety data collection, processing and reporting; global regulatory requirements for pharmacovigilance.
• Excellent verbal and written communication in English and local language; ability to convey complex information clearly.
• Ability to work collaboratively in a team; sound judgment in complex, ambiguous situations.
• High attention to detail and thorough, reliable work product.

Responsibilities

• Serve as primary Product Safety Lead for studies of moderate to high complexity.
• Lead study-level safety governance, planning, execution, and reporting activities.
• Develop, author, and maintain Safety Management Plans aligned with protocols and sponsor expectations.
• Act as primary Product Safety contact for sponsors and project teams; manage safety communications.
• Lead safety meetings, document decisions, and track actions to completion.
• Oversee study safety scope, timelines, budgets, and risk escalation.
• Provide guidance to safety staff and review deliverables.
• Contribute to study safety strategy for proposals and bid defenses.
• Conduct risk assessments and escalate findings for senior review.
• Mentor junior safety team members and support training content.

Skills

Safety leadership

Regulatory knowledge

Pharmacovigilance

Risk assessment

Communication skills

Team collaboration

Study governance

Education

Bachelor’s degree (RN, Health Sciences, PharmD) or equivalent

Tools

Argus

Excel

Word

PowerPoint

Job description

RHO Inc is seeking a Senior Safety Specialist to join its Product Safety Team. The role is remote and open to candidates in Poland, the UK, or Spain. You will oversee study safety governance, develop safety plans, and act as the primary contact for sponsors and internal teams.

You will lead safety data collection, reporting, and compliance with global pharmacovigilance regulations, while mentoring junior staff and supporting training. Fluency in English and local language is required.