Clinician, Product Safety and Performance-9835140502
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Clinician, Product Safety and Performance in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Clinician, Product Safety and Performance is responsible for activities related to product safety surveillance and risk management including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues. He/she reviews and prepares reports on aggregate data and provides recommendation for further escalation. This individual will prepare complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs.
The Clinician, Product Safety and Performance will provide guidance to complaint handling specialist regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint. He/she will provide clinical guidance and validates correct coding and regulatory reporting of complaint files by reviewing daily complaint reports. This individual will maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events. The Clinician, Product Safety and Performance will assess customer complaints for potential regulatory reporting, based on product specific criteria. He /she will verify assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling. This individual will compose clinical conclusion to be included in the reports to competent authorities around the world. He/she will evaluate investigational findings for appropriateness and any significant issues. The Clinician, Product Safety and Performance will review technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports. He/she will review weekly complaint report to identify any significant issues that need to be escalated or expedited. This individual will develop malfunction code list and regulatory reporting tables is support of product launch activities (preparing surveillance system to capture data). The Clinician, Product Safety and Performance will monitor customer complaint data for product quality trends. He/she will review monthly surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns. He/she will complete health hazard evaluation assessments. He/she will review monthly safety surveillance data with manufacturing sites. This individual will represent Quality Clinical interests in multi-disciplinary teams during product development. The Clinician, Product Safety and Performance will perform clinical reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA's, Risk Management Plan, Risk Management Report and Clinical Evaluation Report in support of new product development and regulatory requirements. He/she is responsible for evaluation and review of non-Clinical contributions to risk management documents such as FMEA's, Risk Management Plans and Risk Management Reports for conformance to procedure, completeness, content and accuracy. This individual will ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes from both a compliance and business perspective. The Clinician, Product Safety and Performance will act as Clinical representative for clinical changes and non-regulatory change assessments to Instructions for Use. He/she will provide clinical complaint review as requested from regulatory bodies for individual complaints, annual reports or for certificate renewal. This individual will coordinate, prepare, or review complaint data for regulatory submissions for domestic or international projects. The Clinician, Product Safety and Performance will provide education and training to employees worldwide about products, best practice to report complaints and return complaint products. He/she will participate in site or global projects and improvement efforts, as needed. This individual will participate in internal or external audits.
Qualifications
To be considered for the role a minimum of a Bachelor’s Degree in Nursing, Life Sciences or Health Sciences is required. A minimum of 6 years of professional experience is required. A minimum of 4 years in a GMP and/or ISO regulated industry strongly preferred. A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is also strongly preferred. Experience in post market regulatory, quality or compliance areas is preferred. The ability to work independently and prioritize with little supervision is required. Strong written and oral communication and interpersonal (listening) skills is required. The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required. Familiarity with basic quality tools and techniques is preferred. Analytical and critical thinking skills are required. Excellent organizational and time management skills are required. RAC or ASQ certifications are preferred. Strict attention to detail is required.
This position will be based in West Chester, PA and will require up to 10% travel, including potential international.
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Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Travel:Yes, 10 % of the Time
Job Function: Quality (Eng)
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