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Precision for Medicine, a Clinical Research Organization, is seeking a Safety Specialist to join its growing team. The role focuses on clinical trial safety management, including serious adverse event (SAE) case management from intake through regulatory reporting, and providing safety expertise to internal teams, clients, and study site personnel.
Key responsibilities include:
- Developing and implementing safety management plans
- Designing and implementing safety collection tools, processes, and reporting systems in collaboration with sponsors and vendors
- Setting up and maintaining safety databases to capture SAE data
- Performing intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives for individual case safety reports (ICSRs)
- Quality control of safety documents and reports
- Preparing and reviewing project-specific safety reporting plans and medical coding plans
- Creating and reviewing safety training materials
- Providing safety training and oversight for consultants, contractors, and staff
- Drafting and reviewing standard operating procedures and work instructions
- Supporting clients and departmental staff with safety-related reviews
Required qualifications:
- Bachelor's degree (BA/BS)
- Minimum 5 years of safety experience in clinical research or pharmaceutical settings
- Healthcare professional background
- Hands-on experience with global safety databases and SAE case processing
- Working knowledge of MedDRA and WHODrug medical coding systems
- Knowledge of FDA safety regulations, ICH guidelines, and global safety regulations
Preferred qualifications:
- Nursing or pharmacy degree
- Clinical trial safety experience
- Experience with Argus safety database software
- Prior experience at a CRO or pharmaceutical company
