Safety Lead
Accountabilities: The Safety Lead is responsible for overseeing clinical safety and pharmacovigilance activities, providing expert guidance, and ensuring accurate, compliant safety operations across assigned projects. This role acts as a central resource for safety-related decision-making, process improvement, and collaboration with internal and external stakeholders.
Support project-specific safety activities, including meetings, teleconferences, governance discussions, and study planning activities.
Develop and oversee safety management plans, processes, and operational strategies.
Manage serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) case activities from intake through regulatory reporting.
Partner with sponsors, vendors, study teams, and internal stakeholders to design and implement safety collection tools, reporting systems, and workflows.
Participate in safety database assessment, setup, and ongoing management activities.
Review and quality control safety documentation, reports, and regulatory submissions as needed.
Prepare and review safety reporting plans, medical coding plans, and safety training materials.
Develop, maintain, and improve standard operating procedures, work instructions, and departmental processes.
Serve as a subject matter expert for clinical safety and pharmacovigilance activities.
Provide training, coaching, and mentorship to Safety Specialists and other team members.
Support audits, inspection readiness activities, regulatory inspections, and CAPA management processes.
Participate in client bid defenses and support business development initiatives.
Oversee safety-related project activities, including standalone safety projects and cross-functional initiatives.
Support SAE/AESI query generation, tracking, escalation, and resolution activities.
Provide guidance on regulatory agency responses related to safety and pharmacovigilance matters.
Assist clients and internal teams with safety reviews, assessments, and specialized safety services.
Requirements:
The ideal candidate is an experienced clinical safety professional with extensive pharmacovigilance expertise and a strong understanding of global regulatory requirements. This role requires excellent communication skills, analytical ability, and the confidence to manage complex safety activities across multiple stakeholders.
Bachelor’s degree in a relevant field required.
10+ years of clinical safety experience.
5+ years of pharmacovigilance experience.
Healthcare professional background preferred.
Hands-on experience with global safety databases, SAE case processing, and safety report generation.
Strong knowledge of MedDRA and WHODrug coding systems.
Working knowledge of FDA safety regulations, ICH guidelines, and global pharmacovigilance requirements.
Demonstrated experience supporting clinical trial safety reporting, regulatory inspections, BLA/NDA approval inspections, and audit readiness activities.
Strong written and verbal communication skills with the ability to explain complex clinical and regulatory concepts clearly.
Excellent judgment, analytical thinking, and problem-solving abilities.
Ability to work effectively in a fast-paced, innovative environment while remaining adaptable and proactive.
Strong organizational skills with the ability to manage competing priorities.
Experience in a Clinical Research Organization (CRO) or pharmaceutical environment preferred.
Nursing or pharmacy degree preferred.
Project management experience preferred.
Benefits:
Competitive salary range of $110,700 – $166,100 USD .
Eligibility for discretionary annual bonus opportunities.
Comprehensive health insurance benefits.
Retirement savings benefits.
Life insurance and disability coverage.
Paid time off, including vacation and sick leave.
Parental leave benefits.
Remote work flexibility.
Opportunities to contribute to innovative clinical research programs.
Professional growth and development opportunities.
How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?
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