Clinician, Product Safety and Quality

Cardinal Health - Florida

Full-time
JOB DESCRIPTION SUMMARY

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, literature reviews, complaints, regulatory reporting, product evaluations, statistical trending and potential safety issues. This individual reviews and prepares reports on aggregate data and provides recommendation for further escalation. Prepares Complaint Trend Analysis, product risk assessments including Health Hazard Evaluations, risk management documents and FMEAs. Assist in benchmarking best practices with world class organizations, interface with notified bodies, and/or other regulators and provide input to establish metrics. Interacts with internal and external manufacturing entities as Safety Surveillance representative.

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. Contacts customers as needed.
Provide clinical guidance and validate correct coding and regulatory reporting determination of complaint files by reviewing daily complaint reports and published literature.
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
complaint files
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
Review of technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports. Evaluate and provide feedback; evaluate need for escalation.
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 is support of product launch activities (preparing surveillance system to capture data)
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
Complete Trend Analysis and make recommendations for further escalation when appropriate
Complete Distributed Product Risk Assessment Health Assessment portion and participate in Management Review discussions by providing surveillance data analysis and severity assessment per risk management documentation
Lead monthly risk management/complaint meetings with manufacturing sites
Review monthly safety surveillance data with both Cordis and OEM manufacturing sites
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
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 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 Medical Safety 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 and audits.
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 communicating business related issues or opportunities to next management level
For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
Performs other duties assigned as needed

EDUCATION/TRAINING and/or EXPERIENCE:
Must possess a Registered Nurse (RN) degree/ license
A minimum of a Bachelor's degree in Nursing or a scientific discipline is preferred
A minimum of 5 years of Interventional Radiology/Cardiology or ICU experience is preferred
Experience using vascular interventional devices is preferred
Regulatory Affairs/ Quality Assurance and/or complaint handling experience in the Pharmaceutical or Medical Device industry is preferred
Experience with health hazard evaluations is preferred
Experience interacting with the FDA is preferred
Risk Management experience is preferred
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

Knowledge of medical terminology is required
Knowledge of regulatory reporting requirements preferred
The ability to collaborate in a cross-functional team environment is required
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required
Excellent written and oral English communication skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine qualification and submission reports and routine correspondence
Ability to speak effectively before groups of employees of organization
Knowledge of computer application programs including Excel, PowerPoint and Word processing
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to travel at least once a month

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.