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Safety Associate

Remote: 
Full Remote
Contract: 
Full time
Work from: 
United States

Offer summary

Qualifications:

Bachelor's degree or RN in life sciences or healthcare related field., Minimum of 3 years in a related field with at least 1 year of direct experience in clinical studies, preferably in drug/device safety., Strong communication skills and excellent organizational abilities are essential., Thorough knowledge of clinical research processes and applicable safety regulations is required..

Key responsabilities:

  • Assist with planning, implementation, and execution of safety management activities under the guidance of the Safety Manager.
  • Process safety data and perform pharmacovigilance tasks, including tracking adverse events and regulatory reporting.
  • Support safety committee coordination and contribute to the development of project-specific safety management plans.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements related to device safety.

RQM+ logo
RQM+ SME https://www.rqmplus.com/
501 - 1000 Employees
See all jobs

Job description

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.

Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.

We don’t make MedTech. We make MedTech happen.

RQM+ clinical trial services maintains the highest level of integrity and brings unique value to MedTech manufacturers. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency

The Safety Associate (SA) assists with successful planning, implementation, and execution of contracted safety management activities. Under the guidance of the Safety Manager, the SA is responsible for monitoring and processing Adverse Events, supporting CEC and DSMB management, assisting with applicable regulatory reporting, and serving as a resource on safety-related issues. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by RQM+ and its clients.

Primary Responsibilities
  • Exhibit subject matter expertise in clinical trial safety.
  • Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
  • 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 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; onboarding members, manage and facilitate meetings, prepare materials, document maintenance, and liaising with study personnel.
  • Ensure to meet the expected productivity, quality standards and delivery standards per project requirements.
  • 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.

    • Requirements
  • 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. 
  • Ability to work in an intense, fast-paced, multinational work environment.
  • Ability to effectively communicate with employees, colleagues, and global teams 
  • Positive motivator
  • Customer and results orientation
  •  Bachelor's degree or RN in life sciences or healthcare related field.
  • Minimum of 3 years in related field. Minimum of 1-year direct experience in clinical studies, preferably in drug/device safety.
  • Equivalent combination of education, training, and experience
  • Thorough knowledge of clinical research process.
  • Applicable knowledge and understanding of safety events 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) preferred.
  • Excellent attention to detail and accuracy, maintain high quality standards.
  • Good working knowledge of Microsoft Office and web-based applications.
  • Self-motivated and flexible.
  • Excellent organizational 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.
  • Strong time management skills.
  • Ensure quality of deliverables according to the agreed terms.
  • Flexibility to operate in shifts.

    • Behaviors
  • Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
    • Being an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

    We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

    Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

    We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.


    Job Opportunity Verification
    At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:
    All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
    Every candidate going through the interview process will participate in a voice and/or video interview.
    Exercise caution with unsolicited job offers or requests for sensitive information.

    Required profile

    Experience

    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Hard Skills

    Clinical Trial PlanningStatutory LawAdverse Event MonitoringPharmacovigilanceData EntryMedical AbbreviationsProcess SafetyRisk AnalysisSafety Management SystemsClinical ResearchElectronic Data Capture (EDC)

    Other Skills

    • Communication
    • Time Management
    • Organizational Skills
    • Physical Flexibility
    • Social Skills
    • Self-Motivation
    Are you interested?

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