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.
Telephonic / Skype
- 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.
- 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.
- 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.
- Experience in clinical risk management. Experience in medical device industry..
Bachelor’s Degree in Nursing required, Advanced Practice Nurse or Master’s level degree preferred.
Active nursing license. – provided by Dice
To Apply: https://www.jobg8.com/Traffic.aspx?a8kf%2bMYAJonvGCU%2bR45zYgq