Principal Safety Specialist

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Principal Safety Specialist?  

Position Summary:

Responsibilities will include but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

Essential functions of the job include but are not limited to:

• 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

Qualifications:

Minimum Required:

• BA/BS degree
• 10+ years clinical safety experience 

Other Required:

• 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

Preferred:

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