Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson. Learn more about Biosense Webster at www.biosensewebster.com. The Quality Systems department in Medical Affairs is recruiting for a Senior Clinician in Product Safety & Performance, located in either Irwindale, Ca or Irvine, Ca.
The Senior Clinician, Product Safety & Performance will:
• Be 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.
• Review and prepare reports on aggregate data and provide recommendation for further escalation.
• Prepare complaint trend analysis.
• Provide guidance to Complaint Handling Specialists regarding investigation of product related events reported worldwide from patients, customers, clinical account specialists and clinical studies/registries in order to assess product relationship to reported complaint.
• Provide clinical guidance and validate correct coding and regulatory reporting of complaint files by reviewing daily complaint reports.
• Maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events.
• Assess customer complaints for potential regulatory reporting, based on product specific criteria. Verify that assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling.
• Compose clinical conclusion to be included in the reports to competent authorities around the world.
• Evaluate FAL findings for appropriateness and any significant issues. S/he will perform reviews of technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports.
• Perform reviews of weekly complaint reports to identify any significant issues that need to be escalated or expedited.
• Maintain malfunction code list and regulatory reporting tables is support of product launch activities (preparing surveillance system to capture data).
Monitor customer complaint data for product quality trends.
• Review of monthly surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns.
• Participate in monthly trending board meeting and provide input on actions taken for identified signals.
• Complete Trend Analysis and make recommendations for further escalation when appropriate. Represent Quality Clinical interests in multi-disciplinary teams during product development.
• 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.
• Evaluate and review of non-Clinical contributions to risk management documents such as FMEAs, Risk Management Plans, Risk Management Reports and Distributed Product Risk Assessments for conformance to procedure, completeness, content and accuracy.
• Ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes from both a compliance and business perspective.
• Act as Clinical representative for clinical changes and non-regulatory change assessments to Instructions for Use.
Provide clinical complaint review as requested from regulatory bodies for individual complaints, annual reports or for certificate renewal.
• Coordinate, prepare, or review complaint data for regulatory submissions for domestic or international projects.
• Provide education and training to employees about products, best practice to report complaints and return complaint products.
• Participate in internal or external audits.
• A minimum of a Bachelor's Degree is required.
• A Bachelor's Degree in a health science field, Registered Nurse (RN) Degree/License, RPh, Phar.D. or equivalent is preferred.
• Knowledge of medical terminology is required.
• A minimum of 5 years of nursing and/or industry experience is required.
• Experience in scientific research is preferred.
• Regulatory Affairs/ Quality Assurance and/or complaint handling experience in the Pharmaceutical or Medical Device industry is preferred.
• Knowledge of regulatory reporting requirements is preferred.
• Experience with health hazard evaluations is preferred.
• Experience interacting with the FDA is preferred.
• Risk Management experience is preferred.
• Excellent communication and analytical skills are preferred.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
• The ability to collaborate in a cross-functional team environment is required.
• This position is located in either Irvine, CA or Irwindale, CA and may require <15% travel.
Biosense Webster Inc. (6010)
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