Safety Lead — Clinical Trials & SAE Reporting

Precision Medicine Group; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Precision Medicine Group is seeking a Safety Specialist/Safety Lead to join our clinical safety team. You will develop safety management plans, manage SAE/SUSAR case processing, and provide safety expertise to study teams, clients, and site personnel.

Responsibilities include safety database setup, safety reporting planning, training material development, and collaboration with sponsors and vendors to ensure regulatory compliance and timely safety submissions.

Qualifications

• BA/BS degree required in healthcare or related field.
• Minimum 5 years safety experience in clinical research or pharma.
• Hands-on experience with global safety databases and SAE case processing.

Responsibilities

• Develop safety management plans and oversee SAE/SUSAR processing.
• Provide safety expertise to team members, clients, and site personnel.
• Interface with sponsors and vendors to design safety collection tools and reporting.
• Set up and maintain safety databases and safety reporting plans.
• Review safety documents and training materials; provide training as needed.
• Assist with safety reviews and other departmental services.
• Other duties as assigned.

Skills

Safety management

SAE processing

Regulatory reporting

FDA regulations

ICH guidelines

Global safety regulations

Education

BA/BS degree

Nursing or Pharmacy degree preferred

Tools

Argus

MedDRA

WHODrug

Job description

Precision Medicine Group is seeking a Safety Specialist/Safety Lead to join our clinical safety team. You will develop safety management plans, manage SAE/SUSAR case processing, and provide safety expertise to study teams, clients, and site personnel.

Responsibilities include safety database setup, safety reporting planning, training material development, and collaboration with sponsors and vendors to ensure regulatory compliance and timely safety submissions.