Precision Medicine Group is hiring a
Principal Safety Specialist

Summary

The Principal Safety Specialist will be responsible for safety management plan development, serious adverse event case management, interfacing with sponsors, vendors, and other internal team members, participating in audits and bid defenses, and more. The candidate should have a BA/BS degree and 10+ years of clinical safety experience, be a health care professional, have hands-on experience with global safety databases, MedDRA, WHODrug, FDA safety regulations, ICH guidelines, and global safety regulations. Preferred qualifications include a nursing or pharmacy degree and industry experience in CRO or pharmaceutical company. The role is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation.

Requirements

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

Responsibilities

• Safety management plan development
• Serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting
• Providing safety expertise in a timely manner upon request from team members, clients, and study site personnel
• Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems
• Participate in the assessment and set-up of a safety database to capture SAE data
• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures
• 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
• 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 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
• Assist clients and/or other departmental staff with safety-related reviews and other services

Preferred Qualifications

• Nursing or pharmacy degree
• Industry experience in CRO or pharmaceutical company

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation