Safety Associate
$65–$85,000 year
On-siteNew York City, New York, United States or New York, United States
Job Summary
Manage adverse event reports, including SAEs and UADEs, by entering safety data into databases and tracking systems while ensuring completeness and accuracy for expedited reporting. Review safety monitoring documents, coordinate resolution of data queries, and draft MedWatch and CIOMS Forms. Extract data from study portals to prepare listings for Medical Monitor review and provide safety reports to sponsors and project teams. Participate in project meetings, facilitate CEC/DMC/DSMB meetings, and assist with unblinding treatment assignments. Maintain safety records in approved systems and support cross-functional initiatives as assigned.
Required Qualifications
- Bachelor's degree
- at least three years of drug safety experience
- Strong knowledge of US federal regulations
- Strong knowledge of ICH guidelines
- Strong knowledge of HIPAA
- Strong computer skills
- knowledge of safety database management
- knowledge of clinical data management systems
- proficiency in at least two EDC platforms
- Excellent interpersonal skills
- ability to work well with sponsor representatives
- ability to work well with Medical Monitors
- ability to work well with clinical investigators
- ability to work well with site personnel
- ability to work well with multidisciplinary project team members
- Excellent communication skills
- verbal communication skills
- written communication skills
- presentation skills
- ability to plan
- ability to prioritize
- ability to manage a workload independently
- high degree of initiative
- attention to detail
- problem solving skills
- successful resolution of problems
- proactivity
Desired Qualifications
- Bachelor's degree, preferably in science or a health-related field
- MedDRA coding certification
- combination of education, training and experience in lieu of the three years of drug safety experience
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