Safety Lead
Core
Senior clinical safety and pharmacovigilance role supporting complex clinical research projects, overseeing safety processes, case management, and regulatory reporting.
Role type
Senior IC clinical safety lead (pharmacovigilance)
Builds
Safety management plans, reporting systems, and regulatory submissions for clinical trials
Domain
Clinical research / Pharmacovigilance
Required skills
SAE/SUSAR case management, safety database administration, regulatory reporting (FDA/ICH), audit/inspection readiness, SOP development, query resolution, project management
Preferred skills
Nursing or pharmacy degree, CRO or pharma industry experience, project management certification
Technologies
Global safety databases, MedDRA, WHODrug
Responsibilities
Lead project-specific safety activities including kick-off meetings and safety planning; Develop and manage safety management plans, reporting plans, and SOPs; Oversee SAE/SUSAR case management from intake to regulatory reporting; Interface with sponsors and vendors to design safety collection tools; Perform quality control of safety documentation and reports; Provide oversight of query resolution and escalation; Prepare or review safety training materials and mentor Safety Specialists; Participate in audits, inspection readiness, and regulatory agency inspections; Support client safety reviews and bid defenses.
Seniority
Senior, hands-on IC with strategic leadership
