Job Title: Safety Specialist (Remote)
Contract Length : 12 months (extension possibilities)
This position will be responsible for providing medical and clinical expertise to support patient safety throughout the product life cycle.
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
- Escalate newly identified potential safety issues for further
- 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
- 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
- Serve as expert reviewer for the Post-Market Surveillance Plan and Clinical Evaluation Report.
- Provide safety input to risk management
- Participate in the development and maintenance of Medical Safety processes and Standard Operating
- 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
- Ability to assess clinical outcomes, analyze data, summarize, and present
- Ability to perform comprehensive literature
- Proficient in Microsoft Office applications, including Excel, Word and
- Excellent written and oral English communication
- Project management
- Strong work ethic, patient focus, and commitment to serve internal and external
- Proactive with a sense of urgency in managing job
- Energy, focus, motivation and debate
- Analytical thinking and inquisitive mindset for investigations and problem
- Team player, "can-do" attitude, and excellent interpersonal
- Ability and desire to develop good working relationships internally and
- Practice and share accountability with others for a positive team spirit characterized by mutual support of corporate culture, understanding, encouragement.
Bachelor's Degree in Nursing required, Advanced Practice Nurse or Master's level degree preferred.
Active nursing license.