Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Safety Specialist/Safety Lead role.
Rezi rewrites your resume against Precision Medicine Group's job description. Free.
Tailor your resume to this Safety Specialist/Safety Lead role.
Rezi rewrites your resume against Precision Medicine Group's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Safety Specialist/Safety Lead posting at Precision Medicine Group — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Safety Specialist/Safety Lead posting at Precision Medicine Group — free, in seconds.
About the Role
Precision for Medicine is a Clinical Research Organization that enables the science of precision medicine through integrated novel clinical trial designs, expert operational and medical teams, advanced analytics, and a passion for rare diseases and oncology. We are seeking a Safety Specialist/Safety Lead to join our growing team.
Responsibilities
- Develop safety management plans.
- Manage serious adverse event (SAE, SUSARS) cases from intake to regulatory reporting.
- Provide safety expertise to team members, clients, and study site personnel.
- Interface with sponsors, vendors, and internal team members to design and implement safety collection tools, processes, and reporting systems.
- Participate in the assessment and set-up of a safety database for SAE data capture.
- Perform intake, triage, data entry, medical coding, expectedness assessment, and narrative composition for individual case safety reports (ICSRs).
- Perform analysis of similar events for ICSRs, following applicable regulations and company policies.
- Conduct quality control of documents and safety reports.
- Prepare and/or review project-specific safety reporting plans and medical coding plans.
- Prepare and/or review safety training materials.
- Provide safety training and oversight for consultants, contractors, and staff.
- Review and/or draft standard operating procedures and work instructions.
- Assist clients and departmental staff with safety-related reviews and services.
- Perform other duties as assigned.
Requirements
- BA/BS degree
- Minimum 5 years of safety experience
- Healthcare professional
- Hands-on experience with global safety database(s)
- Hands-on experience with SAE case processing including narrative writing
- Hands-on experience with safety reports generation
- Working knowledge of MedDRA and WHODrug
- Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.
Skills
- Safety management plan development
- Serious adverse event (SAE, SUSARS) case management
- Regulatory reporting
- Safety database assessment and set-up
- Medical coding
- Narrative writing
- Analysis of similar events
- Quality control of documents and safety reports
- Safety reporting plan preparation
- Medical coding plan preparation
- Safety training material preparation
- Safety training and oversight
- Standard operating procedure review/drafting
- Work instruction review/drafting
- Safety-related reviews
Experience Level
- Minimum 5 years safety experience
Education Level
- BA/BS degree
- Nursing or pharmacy degree preferred
About the Company
- Precision for Medicine is a Clinical Research Organization.
- Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
Equal Opportunity
- Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
- If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.