Safety Lead

Accountabilities

• Oversee clinical safety and pharmacovigilance activities, providing expert guidance, and ensuring accurate, compliant safety operations across assigned projects.
• Absorb responsibility 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.
• 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 pharmacovigivalence matters.
• Assist clients and internal teams with safety reviews, assessments, and specialized safety services.

  Requirements

  • An experienced clinical safety professional with extensive pharmacovigilance expertise and a strong understanding of global regulatory requirements.
  • 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.
    • Retail 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.