Principal Safety Specialist
Remote, United States
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 stagesâfrom early development through approvalâwith 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. Wonât you join us today as a Principal Safety Specialist? Â
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 experienceÂ
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
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Regions Countries Benefits/PerksDisability benefits Discretionary annual bonus Health insurance Life Insurance Paid Time Off Paid time off for sick leave and vacation Parental leave Retirement savings Retirement savings benefits
SkillsClinical operations Clinical Research Data sciences Design Development ICH Guidelines Laboratory expertise Management Medical Coding Oncology Rare Disease Resource Management
Tasks- Data entry
- Project management
- Resource management
10+ years
EducationBA/BS degree Business Pharmacy degree
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9