Safety Lead

Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Requirements

• Project specific teleconferences/meetings
• Safety budget review and approval
• Safety management plan development
• Oversight of serious adverse event (SAE, SUSARS) case management
• Providing safety expertise
• Interfacing with sponsors, vendors, and internal team members
• Participate in the assessment and set-up of a safety database
• QC of documents and safety reports
• Preparation and/or review of project specific safety reporting plans and medical coding plans
• Preparation and/or review of safety training materials
• Review of Safety related budget tasks and activities
• Develop and manage standard operating procedures and work instructions
• Serve as subject matter expert for department
• Provide ongoing training and mentorship for Safety Specialists
• Participate in audits and audit preparation, kick-off meetings, and investigator meetings
• Participate in the CAPA management process
• Participate in bid defenses for existing and potential clients
• Assist departmental management with resource management
• Assist departmental management with oversight
• Serve as project manager for safety standalone projects
• Lead departmental initiatives and cross-functional development activities
• Support the generation of SAE/AESI queries and tracking
• Provide input and review of responses to regulatory agency questions
• Assist clients and/or other departmental staff with safety-related reviews and other services

Benefits

• Competitive salary
• Benefits package
• Opportunities for growth and development