Location: Lake County, IL (AbbVie Headquarters) and open to other AbbVie office locations  in the US.

Purpose:

Medical Device Safety Physician leads the safety oversight relevant to her/his assigned products to determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects. Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, medical writing, clinical development, clinical operations, manufacturing, epidemiology, marketing and other functional areas to identify, evaluate, and communicate safety issues.  May contribute relevant clinical safety input to new product design teams as needed. 

The Medical Device Safety Physician is independently responsible for proactive safety strategy, medical safety assessment of SAE/AEs reported to Product Surveillance, clinical study safety management, contribution to post market surveillance activities,  input to compliant regulatory authority reporting, development and implementation of lifecycle safety risk management strategies and communication of safety information for assigned medical device development, clinical studies and marketed products. He/She monitors and manages the ongoing safety profile of products to maximize the understanding of risks and benefits for providers, patients, consumers, study subjects and the environment through proactive review of all relevant pre- and post-marketing safety data, medical analysis and decision making.

Responsibilities:

Device, Combination Products, and InVitro Diagnostics, Clinical Trials- Medical assessment and Management

• Responsible for safety aspects clinical trials including drafting and/or review of the Safety Management Plan and relevant safety chapters/text of key clinical trial documents such as informed consent, protocols (specifically inclusion / exclusion criteria, Adverse Event management and reporting, and AEs of interest).
• Evaluates all safety data generated in clinical trials on a contemporaneous basis. 
• Provide medical leadership on global teams on safety related issues.
• Responsible for overall evaluation, assurance, and reporting of safety of subjects in clinical trials and clinical development program.
• Performs medical assessment of Serious Adverse Events including causality assessment, determination of expectedness, identification of events of interest, sentinel events and additional follow up for pre-and post-marketed products as appropriate.
• Provides medical safety input as appropriate to Global Product Teams regarding expectedness, causality, data reconciliation and analysis of safety data.
• Review and approve final listings of SAEs, AE, AE of special Interest, and other listings based on the clinical study requirements.
• Responds to safety questions from investigator sites and IRBs regarding safety issues and queries.
• Provides medical safety interpretation of safety findings for all clinical study reports, including final review of safety relevant adverse event coding for assigned projects and discusses, proposes, and communicates any revision(s) or additions
• Contribute to integrated safety summaries, risk/benefit assessments, and other relevant safety sections or documents in support of regulatory submissions and periodic or update reports.
• Ensures accurate, relevant, and meaningful CSR data and insights.
• Liaises with assigned Data Safety Monitoring Boards. 
• Responds to safety questions from investigator sites and IRBs regarding safety issues and queries. 

Post-market/Product Surveillance Safety

• Ensure appropriate assessment of product complaints requiring medical interpretation for assigned products
• Ensure appropriate medical assessment and determinations have been documented prior to submission of reports, including MDRs, to regulatory authorities.
• Provide medical input and assessment to regular and ad hoc product surveillance and safety reports for publication to regulatory authorities
• Provides medical support for reportability decisions and accurate coding for device adverse events and malfunctions

Risk Management & Regulatory support

• Contribute to the assessment of newly identified and potential risks for development of risk management plans and risk minimization activities.
• Contributes to the development and on-going review/revision of assigned product(s) Clinical Hazards Lists (CHL) and Application Failure Mode and Effects Analysis (aFMEAs)
• Reviews device risk management documents such as AE Matrix, Risk Management Plans, Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports
• Participates in Health Product Hazard Assessments and Health Hazard Evaluations
• Contribute to writing safety responses to regulatory authorities
• Review literature to support submission of new device applications

Review Safety Data Information for Instructions for Use (IFU) to ensure accurate device labeling

New Product (Device, Combo, IVD) Development

Participates as a Core Team Member on New Product Development projects as assigned

SOP Development & Training, Personnel Development

• Contributes to the mentoring of colleagues in clinical safety management.  Provide technical knowledge to Device Safety Analysts as needed

• Develops and maintains comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned product portfolio and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions
• Assist in development of new clinical safety documents as required by clinical studies and assist in updating current Device SOPs

Leads or contributes as an individual to projects / process improvements that support PSEQ’s strategic objectives