Safety Sphere
Safety Sphere, LLC is a women-owned business with over 20 years of pharmacovigilance experience, specializing in drug safety and pharmacovigilance consulting services for small to mid-size pharmaceutical companies, emerging biotechs, and CROs. They focus on ensuring regulatory compliance, supporting drug safety teams, and providing customized pharmacovigilance solutions.
Industries
Nr. of Employees
small (1-50)
Safety Sphere
P.O. Box 842086, Pearland, TX 77584
Services
Tailored consulting services to design and operate drug safety processes aligned to client needs across clinical development and marketed products.
Design and build-out of departmental structure, staffing plans, and operational workflows from early phase through commercial operations.
Implementation, configuration, vendor evaluation, and validation of electronic safety database systems, including support for SaaS and on-premises deployments.
Audit readiness assessments, mock audits, training, and remediation planning to prepare for regulatory inspections and maintain compliance.
Establishment of signal detection processes, safety surveillance workflows, and facilitation of aggregate safety and risk management meetings.
Development of SOPs, templates, and training programs to operationalize pharmacovigilance processes and ensure staff competency.
Tailored consulting services to design and operate drug safety processes aligned to client needs across clinical development and marketed products.
Design and build-out of departmental structure, staffing plans, and operational workflows from early phase through commercial operations.
Implementation, configuration, vendor evaluation, and validation of electronic safety database systems, including support for SaaS and on-premises deployments.
Audit readiness assessments, mock audits, training, and remediation planning to prepare for regulatory inspections and maintain compliance.
Establishment of signal detection processes, safety surveillance workflows, and facilitation of aggregate safety and risk management meetings.
Development of SOPs, templates, and training programs to operationalize pharmacovigilance processes and ensure staff competency.
Expertise Areas
- Pharmacovigilance and drug safety operations
- Regulatory compliance and audit preparedness (FDA, ICH, international)
- Safety database implementation and validation
- Signal detection and safety surveillance
Key Technologies
- Electronic safety database systems (SaaS and on-premises)
- Standardized adverse event and drug coding (e.g., MedDRA-like, WHO-like)
- Signal detection methodologies and surveillance workflows
- 21 CFR Part 11 compliance and system validation