RQM+ · 3 hours ago
Safety Associate
United States
Full-time
Onsite
Mid Level
3+ years expRQM+ is a MedTech CRO that accelerates innovation to patient impact. The Safety Associate is responsible for assisting with safety management activities, monitoring adverse events, and ensuring compliance with regulations while supporting clinical trials.
Health CareMedicalMedical Device
Hiring Manager
Jessica Miller
Responsibilities
Exhibit subject matter expertise in clinical trial conduct and safety with a focus on medical device studies, as well as combination products and software as medical device
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
Gathers, reviews and interprets source documentation from clinical sites to formulate a cohesive narrative for safety events
To perform Pharmacovigilance per project requirement including but not limited to, collecting, and tracking incoming Adverse Events(AE)/endpoint information
Determine initial/update status of incoming events
Review and evaluate adverse events to determine if they meet regulatory reporting requirements
Database entry in commercial and validated safety database
Coding AEs in accordance with MedDRA and WHODictionary and writing case narratives, literature related activities as per internal / project timelines
Assist in development of project-specific safety management plan, safety committee charters, procedures, workflows, and templates
Safety Committee support and coordination; obtain electronic signatures, onboarding members, member management, manage and facilitate meetings, prepare materials, assist with documentation, document maintenance, and liaising with study personnel
Ensure to meet the expected productivity, quality standards and delivery standards per project requirements and department KPIs
Identify quality problems, if any, and bring them to the attention of a senior team member
Contribute to identification, development, and implementation of safety management initiatives and process improvements
Assist with risk assessment activities and implementation of effective control measures and corrective action solutions, as required
To mentor new team members, if assigned by the Sr. Manager
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes
Collaborate with cross-functional teams to ensure compliance with regulatory requirements related to device safety and pharmacovigilance
Prioritize and complete the assigned training on time. Perform other duties as assigned
Qualification
Required
Bachelor's degree or RN in life sciences or healthcare related field
Minimum of 3 years in related field. Minimum of 3-years direct experience in clinical studies, preferably in drug/device safety or CRA position
Equivalent combination of education, training, and experience
Thorough knowledge of and experience in clinical research process from study start up through archiving of TMF, including Interim analysis and database lock
Robust understanding of general anatomy, physiology and pathological processes
Applicable knowledge and understanding of safety events, data queries and reporting relative to medical devices
Knowledge and understanding of global processes, regulations, and reporting requirements for medical device and pharma
Prior or current knowledge of Clinical Event Committee and Data Safety Monitoring Committee workflows
Good knowledge of medical terminology and reporting obligations
Working knowledge of applicable Safety Database and any other internal/Client applications
Knowledge of applicable global, regional, local clinical research regulatory requirements
Prior experience in electronic data capture (EDC) required
Excellent attention to detail and accuracy, maintain high quality standards
Good working knowledge of Microsoft Office, electronic signature platforms and web-based applications
Self-motivated and flexible to meet the needs of the department
Excellent organizational, time management and interpersonal skills
Ability to follow instructions/guidelines, utilize initiative and work independently
Ability to manage competing priorities and deadlines within various clinical trials
Willingness and aptitude to learn new skills across Safety service lines
Ensure quality of deliverables according to the agreed terms
Flexibility to operate in shifts
Up to 20% travel may be required including international travel
Strong communication skills (verbal and written) to express complex ideas
Excellent and demonstrated organizational and interpersonal skills
Excellent verbal and written communication
The ability to work independently, prioritize and work within a matrix team environment is essential
Working knowledge of Word, Excel, and PowerPoint required
Experience with electronic signature platforms required
Ability to work in an intense, fast-paced, multinational work environment
Ability to effectively communicate with employees, colleagues, and global teams
Positive motivator
Internal and external customer focus and results orientation
Benefits
Industry leading compensation package
Deeply engrained focus on work life balance
Company
RQM+
RQM+ is a medical device company providing medical device and post-market surveillance services.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Linden Capital Partners
2021-08-16Private Equity
Leadership Team
John Potthoff
Chief Executive Officer
Recent News
2026-01-09
SS Innovations
2025-10-03
2025-09-23
Company data provided by crunchbase