Safety Lead

• **This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Safety Lead based in United States.**
• The Safety Lead will provide strategic safety and pharmacovigilance expertise to support clinical research programs and ensure compliance with global regulatory requirements.
• This role will oversee safety operations across studies, including adverse event management, reporting processes, documentation, and quality oversight.
• Working closely with clients, internal teams, vendors, and study sites, this position will serve as a trusted subject matter expert throughout the clinical development lifecycle.
• The ideal candidate will bring strong clinical safety experience, regulatory knowledge, and the ability to manage complex safety activities in a fast-paced environment.
• This position offers the opportunity to influence safety strategies, improve processes, mentor teams, and contribute to the delivery of high-quality clinical programs.
• As a key safety leader, this professional will help ensure patient protection while supporting successful regulatory outcomes across global studies.

### 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.