Safety Associate

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.

• 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.

• 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.

• 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.