Overview

IKCON TECHNOLOGIES INC delivers exceptional IT services and solutions that provide clients with definite edge over competitors and promoting highest standards of quality. We are currently looking for a [Safety Specialist] with one of our clients in [UNKNOWN], [NJ]. If you are actively looking for opportunities, please send us your updated resume with your contact details.

JOB TITLE

Safety Specialist

CITY

UNKNOWN

STATE

NJ

TAX TERMS

W2

EXPERIENCE

10+ Years

INTERVIEW MODE

Telephonic / Skype

JOB DESCRIPTION

  • This position will be responsible for providing medical and clinical expertise to support patient safety throughout the product lifecycle.
  • The Safety Specialist is a patient safety advocate and participates in various activities in collaboration with cross-functional team members, including Quality, Regulatory Affairs, Research and Development, Complaint Handling, and Design Quality to support product safety and efficacy.

Essential duties and responsibilities:

  • Evaluate post-market events to identify a potential safety issue and ensure correct coding.
  • Escalate newly identified potential safety issues for further investigation.
  • Provide clinical expertise to support the responses to safety inquiries from internal stakeholders, Food and Drug Administration, or global competent authorities and regulators.
  • Author Medical Safety Assessments for post-market events with a recommended course of action.
  • Author Health Hazard Evaluation to assess the risk of patient harm and present summary of analysis to leadership.
  • Collaborate and provide clinical expertise and knowledge for new products, clinical studies, technical file remediation, and change development process.
  • Serve as expert reviewer for the Post-Market Surveillance Plan and Clinical Evaluation Report.
  • Provide safety input to risk management documents.
  • Participate in the development and maintenance of Medical Safety processes and Standard Operating Procedures.

Essential qualifications:

  • Minimum of ten (10) years of clinical nursing involving direct patient care, preferably in Medical/Surgical and/or Intensive Care Unit (ICU).
  • Knowledge of quality improvement and patient safety across the care continuum.
  • Ability to assess clinical outcomes, analyse data, summarize, and present findings.
  • Ability to perform comprehensive literature reviews.
  • Proficient in Microsoft Office applications, including Excel, Word and PowerPoint.
  • Excellent written and oral English communication skills.
  • Project management skills.

Core skills:

  • Strong work ethic, patient focus, and commitment to serve internal and external clients.
  • Proactive with a sense of urgency in managing job responsibilities.
  • Energy, focus, motivation and debate friendly.
  • Analytical thinking and inquisitive mindset for investigations and problem solving.
  • Team player, “can-do” attitude, and excellent interpersonal skills.
  • Ability and desire to develop good working relationships internally and externally.
  • Practice and share accountability with others for a positive team spirit characterized by mutual support of corporate culture, understanding, encouragement, and an active exchange of new ideas.

Other:

  • Experience in clinical risk management. Experience in medical device industry..

MINIMUM QUALIFICATIONS

Bachelor’s Degree in Nursing required, Advanced Practice Nurse or Master’s level degree preferred.

Active nursing license. – provided by DiceTracking

To Apply: https://www.jobg8.com/Traffic.aspx?a8kf%2bMYAJonvGCU%2bR45zYgq