Safety Specialist/Safety Lead

The role

The Safety Specialist/Safety Lead will manage serious adverse event case management from intake to regulatory reporting. This role involves developing safety management plans and providing safety expertise to team members, clients, and study site personnel.

What you will do

• Develop safety management plans
• Manage serious adverse event (SAE, SUSARS) cases from intake to regulatory reporting
• Provide safety expertise to team members, clients, and study site personnel
• Interface with sponsors, vendors, and internal team members to design safety collection tools, processes, and reporting systems
• Participate in the assessment and set-up of a safety database
• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses for ICSRs
• Perform QC of documents and safety reports
• Prepare and review project-specific safety reporting plans and medical coding plans
• Prepare and review safety training materials
• Provide safety training and oversight for consultants, contractors and/or staff

Required qualifications

• BA/BS degree
• Minimum 5 years safety experience
• Health care professional
• Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
• Working knowledge of MedDRA and WHODrug
• Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations

Nice to have

• Nursing or pharmacy degree
• Clinical trial safety experience
• Hands on experience with Argus
• Industry experience in CRO or pharmaceutical company

About the company

Precision for Medicine is a Clinical Research Organization. Its integrated offering enables the science of precision medicine by combining clinical trial designs, operational and medical experts, and data analytics solutions.