Lead Clinician - Product Safety and Performance

Overview

The Lead Clinician, Product Safety and Performance is responsible for activities related to product safety surveillance and risk management, including review of data from clinical studies, literature reviews, complaints, regulatory reporting, product evaluations, statistical trending and potential safety issues.

Essential Duties and Responsibilities

• Provide guidance to Complaint Handling Analysts 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.
• Code complaint files based on voice of customer information.
• Maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events.
• Compose clinical conclusion to be included in the reports to competent authorities around the world.
• Review of technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports.
• Review of weekly complaint report to identify any significant issues that need to be escalated or expedited.
• Develop malfunction code list and regulatory reporting tables in support of product launch activities.
• Monitor customer complaint data for product quality trends.
• Generation and oversight of monthly statistical triggers.
• 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.
• Review/Approve Trend Analysis and make recommendations for further escalation when appropriate.
• Complete Distributed Product Risk Assessment Health Assessment portion and participate in Management Review discussions.
• 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 FMEAs, Risk Management Plan, Risk Management Report and Clinical Evaluation Report.
• Perform clinical reviews and provide input to Health Hazard Evaluations for known quality issues under investigation.
• Evaluate and review of non-Clinical contributions to risk management documents for conformance to procedure, completeness, content and accuracy.
• Ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes.
• Provide clinical complaint review as requested from regulatory bodies for individual complaints, annual reports or for certificate renewal.
• Provide education and training to employees worldwide about products, best practice to report complaints and return complaint products.
• Participate in site or global projects and improvement efforts, as needed.
• Participate in internal or external audits.
• Provides education and training of Cordis employees about clinical applications of Cordis products.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications

Requires a minimum 8+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or 6+ years and a Master's degree; Or a PhD with 3+ years experience; or equivalent experience. Must possess a Registered Nurse (RN) degree/license.