Senior Safety Specialist
R
RhoClinical research, pharmacovigilance
We are open to this role being located in Poland, UK, or Spain. This is a remote opportunity.Full-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English and local language
- Experience
- 5+ years of product safety/pharmacovigilance experience; 2 years of experience working as a Product Safety Lead on Clinical Trials is required
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Hold a Bachelor’s degree (for example, RN, Health Sciences, or PharmD) or an equivalent combination of education and relevant product safety or clinical research experience.
- Have 5+ years of product safety/pharmacovigilance experience.
- Have 2 years of experience working as a Product Safety Lead on Clinical Trials.
- Have experience developing Safety Management Plans and site training materials and supporting inspections.
- Have strong knowledge of safety data collection, processing, and reporting requirements.
- Have strong knowledge of global regulatory requirements for pharmacovigilance.
- Have advanced knowledge of safety database applications and MedDRA/WHO Drug coding.
- Be proficient in business productivity software such as Excel, Word, and PowerPoint.
- Argus experience is preferred.
- Have verbal, written, and presentation skills in English and the local language.
Responsibilities
- Serve as 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.
- Develop, author, and maintain study-specific Safety Management Plans.
- Act as the primary Product Safety contact for sponsors and internal project teams, managing day-to-day 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 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.
- Contribute study-level safety strategy and operational input to proposals and bid defenses.
- Conduct preliminary or routine risk assessments and participate in training and mentoring junior safety team members.
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