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Clinical Support - Safety Manager
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Organization: Kinetic Concepts, Inc
View Company Profile of Kinetic Concepts, Inc :: View more jobs from Kinetic Concepts, Inc
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Job Description:
Kinetic Concepts, Inc. is a publicly traded (NYSE: KCI) global medical technology company based in San Antonio, Texas with direct operations in 19 countries. With over 6,500 employees and 2007 revenues of approximately $1.61 billion, KCI is one of the fastest growing and most exciting companies in the global medical technology sector. We design; manufacture, market and service a wide range of proprietary products which can help significantly improve clinical outcomes while helping to reduce the overall cost of patient care. More details on KCI can be found at www.kci1.com.
KCI is currently seeking an experienced Clinical Support/Safety Manager who is responsible for:
• Providing 24 hours clinical support to internal and external customers
• Maintaining safe and effective use of KCI products globally through adverse event investigation, risk mitigation, and addressing customer’s safety concerns
• Engaging in risk management of KCI developmental & marketed products through their lifecycle
Including risk reduction, corrective action and product/labeling improvement
• Maintaining personal knowledge of research, trends, and standard of care in the wound care and critical care fields
Detailed responsibilities:
• Respond to safety, clinical and usage queries received from internal and external customers via clinical calls or emails throughout the day, and participate in 24-hour-on-call rotations
• Maintain thorough knowledge of the science of wound healing, KCI products and KCI’s product based publications.
• Review accuracy of the clinical and safety content of literature, including communications to customers regarding KCI therapies, product evaluation and data conclusions
• Collect clinical and safety data regarding KCI products and services, and provide relevant reports to KCI senior management
• Support KCI internal trainings by providing clinical expertise, knowledge and experience on all KCI products
• Participate as extended team member in the new product teams for risk management, and with the clinical trials to review protocols and evaluate adverse events
• Conduct extensive medical investigations of “potential reportable adverse event,” through telephone or electronic communications, and onsite visits when indicated
• Conduct timely investigation in order to ensure compliance with global regulatory timelines for adverse event reporting
• Link findings of new hazards, or increased frequency of the existing hazards, to the product risk documents and contribute to recommendations for product improvements
• Be aware of the trends in adverse events related to the KCI products, and use those as input to implement improvements and reduce risks
• Actively participate in Health Hazard Assessment/Evaluations and Corrective Actions related to marketed products
• Conduct reviews of labeling and marketing material safety information as needed, and contribute to the content by incorporating product safety knowledge
• Collaborate with other functions in the company to engage in active and passive collection of post-market surveillance data and ensure feedback to product improvements and developmental products
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Qualifications:
PREFERRED QUALIFICATIONS:
• Ability to analyze data from various sources, familiarity with data management tools and informatics preferred.
• Degree in nursing informatics a plus.
BASIC QUALIFICATIONS:
• Bachelors degree in nursing, MD or an equivalent with experience in wound care
• Minimum of five years of clinical experience as a registered nurse in critical care or wound care, or equivalent if not a nurse
• Previous field experience with KCI products and services
• Experience with or ability to assimilate knowledge of global regulations, guidelines and standards related to product safety, risk management, post-market surveillance and vigilance.
• Experience in pharmacovigilance and/or risk management in the medical device or pharmaceutical industry is a plus.
• Experience with Microsoft Office Applications (Word, Excel, PowerPoint)
• Excellent verbal and written communication skills
• Willing and able to travel both domestically and internationally
For consideration, please e-mail cover letter, updated resume along with current salary information to: rdresumes@kci1.com.
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| Job Category: |
Bioinformatics |
| Job Status: |
Full Time |
| Location:
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San Antonio, United States |
| Start Date:
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ASAP |
| Salary:
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Undisclosed |
| Contact:
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Janelle Carson |
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Email: |
rdresumes@kci1.com |
| Reference:
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IRC148024-148025 |
| Date Posted:
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5/6/2008 1:35:41 PM |
| Duration:
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