BioSpace
Medical Director, Medical Device, Patient Safety
BioSpace, North Chicago, Illinois, us, 60086
Medical Director, Medical Device, Patient Safety
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 assigned products to determine and advise the course of action necessary to meet safety goals and objectives. Collaborates with cross-functional teams including 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 responsible for proactive safety strategy, safety assessment of SAE/AEs, clinical study safety management, post‑market surveillance input, regulatory reporting support, and lifecycle safety risk management. They monitor and manage the safety profile of products to maximize understanding of risks and benefits for providers, patients, consumers, study subjects and the environment through proactive review of relevant safety data and medical analysis." Responsibilities Device, Combination Products, and InVitro Diagnostics, Clinical Trials - Medical assessment and Management Responsible for safety aspects of clinical trials including drafting and/or review of the Safety Management Plan and relevant safety sections of key clinical trial documents (informed consent, protocols including 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 the 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, AEs, AEs 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. Provide 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 ongoing review/revision of assigned product 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 mentoring colleagues in clinical safety management and provides technical knowledge to Device Safety Analysts as needed. Develops and maintains comprehensive knowledge of the assigned product portfolio and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions. Assists in development of new clinical safety documents as required by clinical studies and assists in updating current Device SOPs. Leads or contributes as an individual to projects or process improvements that support PSEQ’s strategic objectives. Qualifications MD/DO with 2+ years of residency with patient management experience required. Prior device safety experience is preferred in addition to MD/DO. Ability to analyze clinical, post-market, and epidemiological data effectively. Ability to write technical documents with guidance. Ability to work collaboratively in a team environment and to work independently as needed. Ability to present recommendations effectively in group settings. English fluency in writing and speaking. EEO Information / Additional Information The compensation range described is the range of possible base pay compensation the company believes in good faith it will pay for this role at posting time, based on job grade. Individual compensation paid within this range depends on many factors including geographic location and may be higher or lower. Comprehensive benefits including paid time off, medical/dental/vision, and 401(k) for eligible employees. This job is eligible to participate in short-term and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned and vested. The amount and availability of any bonus, benefits, or other compensation remains at the company’s discretion. AbbVie is an equal opportunity employer. Veterans/Disabled. For more information see the provided links for equal employment opportunity and reasonable accommodations. US & Puerto Rico only - learn more at the AbbVie EEO page and reasonable accommodations page. Seniority level
Director Employment type
Full-time Job function
Health Care Provider Industries: Internet News Referrals increase your chances of interviewing at BioSpace by 2x. Get notified about new Medical Director jobs in North Chicago, IL.
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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 assigned products to determine and advise the course of action necessary to meet safety goals and objectives. Collaborates with cross-functional teams including 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 responsible for proactive safety strategy, safety assessment of SAE/AEs, clinical study safety management, post‑market surveillance input, regulatory reporting support, and lifecycle safety risk management. They monitor and manage the safety profile of products to maximize understanding of risks and benefits for providers, patients, consumers, study subjects and the environment through proactive review of relevant safety data and medical analysis." Responsibilities Device, Combination Products, and InVitro Diagnostics, Clinical Trials - Medical assessment and Management Responsible for safety aspects of clinical trials including drafting and/or review of the Safety Management Plan and relevant safety sections of key clinical trial documents (informed consent, protocols including 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 the 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, AEs, AEs 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. Provide 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 ongoing review/revision of assigned product 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 mentoring colleagues in clinical safety management and provides technical knowledge to Device Safety Analysts as needed. Develops and maintains comprehensive knowledge of the assigned product portfolio and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions. Assists in development of new clinical safety documents as required by clinical studies and assists in updating current Device SOPs. Leads or contributes as an individual to projects or process improvements that support PSEQ’s strategic objectives. Qualifications MD/DO with 2+ years of residency with patient management experience required. Prior device safety experience is preferred in addition to MD/DO. Ability to analyze clinical, post-market, and epidemiological data effectively. Ability to write technical documents with guidance. Ability to work collaboratively in a team environment and to work independently as needed. Ability to present recommendations effectively in group settings. English fluency in writing and speaking. EEO Information / Additional Information The compensation range described is the range of possible base pay compensation the company believes in good faith it will pay for this role at posting time, based on job grade. Individual compensation paid within this range depends on many factors including geographic location and may be higher or lower. Comprehensive benefits including paid time off, medical/dental/vision, and 401(k) for eligible employees. This job is eligible to participate in short-term and long-term incentive programs. Note: No amount of pay is considered wages or compensation until earned and vested. The amount and availability of any bonus, benefits, or other compensation remains at the company’s discretion. AbbVie is an equal opportunity employer. Veterans/Disabled. For more information see the provided links for equal employment opportunity and reasonable accommodations. US & Puerto Rico only - learn more at the AbbVie EEO page and reasonable accommodations page. Seniority level
Director Employment type
Full-time Job function
Health Care Provider Industries: Internet News Referrals increase your chances of interviewing at BioSpace by 2x. Get notified about new Medical Director jobs in North Chicago, IL.
#J-18808-Ljbffr