AbbVie
Medical Director, Medical Device, Patient Safety
AbbVie is offering this role at its headquarters Lake County, IL, with open positions also at other U.S. offices.
Base Pay Range $177,000.00/yr - $336,000.00/yr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Location Lake County, IL (AbbVie Headquarters); open to additional AbbVie office locations in the U.S.
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 such as quality systems, regulatory affairs, medical writing, clinical development, manufacturing, epidemiology, marketing, and other functions to identify, evaluate, and communicate safety issues. May contribute relevant clinical safety input to new product design teams as needed.
Responsibilities
Responsible for safety aspects of clinical trials including drafting and/or review of the Safety Management Plan and relevant safety chapters and text of key clinical trial documents such as informed consent and protocols (specifically inclusion/exclusion criteria, adverse event management and reporting, and AEs of interest).
Evaluate all safety data generated in clinical trials on a contemporaneous basis.
Provide medical leadership on global teams regarding safety‑related issues.
Overall evaluation, assurance, and reporting of safety of subjects in clinical trials and clinical development programs.
Perform 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.
Provide medical safety input regarding expectedness, causality, data reconciliation and analysis of safety data to Global Product Teams.
Review and approve final listings of SAEs, AEs, AE of special interest, and other listings based on the clinical study requirements.
Respond to safety questions from investigator sites and IRBs regarding safety issues and queries.
Provide medical safety interpretation of safety findings for all clinical study reports, including final review of safety‑relevant adverse event coding for assigned projects and discuss, propose, and communicate any revisions 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.
Ensure accurate, relevant, and meaningful CSR data and insights.
Liaise with assigned Data Safety Monitoring Boards.
Post‑Market/Product Surveillance Safety
Ensure appropriate assessment of product complaints requiring medical interpretation for assigned products.
Ensure appropriate medical assessment and determinations 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 assessment of newly identified and potential risks for development of risk management plans and risk minimization activities.
Contribute to the development and ongoing review/revision of assigned product(s) Clinical Hazard Lists (CHL) and Application Failure Mode and Effect Analyses (FMEAs).
Review device risk management documents such as AE Matrix, Risk Management Plans, Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports.
Participate 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.
New Product (Device, Combo, IVD) Development Participate as a Core Team Member on New Product Development projects as assigned.
SOP Development & Training, Personnel Development
Mentor colleagues in clinical safety management and provide technical knowledge to Device Safety Analysts as needed.
Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned product portfolio and regulations governing safety data reporting, SOPs, and work instructions.
Assist in development of new clinical safety documents as required by clinical studies and update current Device SOPs.
Qualifications
MD / DO with 2+ years of residency with patient management experience.
Prior device safety experience preferred in addition to MD / DO.
Effectively analyze clinical, post‑market, and epidemiological data.
Effectively write technical documents with direction.
Work collaboratively in a team environment and be self‑starting and able to work independently.
Ability to effectively present recommendation/opinions in a group environment.
Fluency, both written and oral, in English.
Compensation and Benefits
The range described above is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
This job is eligible to participate in our long‑term incentive programs.
Equal Opportunity AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Base Pay Range $177,000.00/yr - $336,000.00/yr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Job Location Lake County, IL (AbbVie Headquarters); open to additional AbbVie office locations in the U.S.
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 such as quality systems, regulatory affairs, medical writing, clinical development, manufacturing, epidemiology, marketing, and other functions to identify, evaluate, and communicate safety issues. May contribute relevant clinical safety input to new product design teams as needed.
Responsibilities
Responsible for safety aspects of clinical trials including drafting and/or review of the Safety Management Plan and relevant safety chapters and text of key clinical trial documents such as informed consent and protocols (specifically inclusion/exclusion criteria, adverse event management and reporting, and AEs of interest).
Evaluate all safety data generated in clinical trials on a contemporaneous basis.
Provide medical leadership on global teams regarding safety‑related issues.
Overall evaluation, assurance, and reporting of safety of subjects in clinical trials and clinical development programs.
Perform 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.
Provide medical safety input regarding expectedness, causality, data reconciliation and analysis of safety data to Global Product Teams.
Review and approve final listings of SAEs, AEs, AE of special interest, and other listings based on the clinical study requirements.
Respond to safety questions from investigator sites and IRBs regarding safety issues and queries.
Provide medical safety interpretation of safety findings for all clinical study reports, including final review of safety‑relevant adverse event coding for assigned projects and discuss, propose, and communicate any revisions 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.
Ensure accurate, relevant, and meaningful CSR data and insights.
Liaise with assigned Data Safety Monitoring Boards.
Post‑Market/Product Surveillance Safety
Ensure appropriate assessment of product complaints requiring medical interpretation for assigned products.
Ensure appropriate medical assessment and determinations 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 assessment of newly identified and potential risks for development of risk management plans and risk minimization activities.
Contribute to the development and ongoing review/revision of assigned product(s) Clinical Hazard Lists (CHL) and Application Failure Mode and Effect Analyses (FMEAs).
Review device risk management documents such as AE Matrix, Risk Management Plans, Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports.
Participate 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.
New Product (Device, Combo, IVD) Development Participate as a Core Team Member on New Product Development projects as assigned.
SOP Development & Training, Personnel Development
Mentor colleagues in clinical safety management and provide technical knowledge to Device Safety Analysts as needed.
Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned product portfolio and regulations governing safety data reporting, SOPs, and work instructions.
Assist in development of new clinical safety documents as required by clinical studies and update current Device SOPs.
Qualifications
MD / DO with 2+ years of residency with patient management experience.
Prior device safety experience preferred in addition to MD / DO.
Effectively analyze clinical, post‑market, and epidemiological data.
Effectively write technical documents with direction.
Work collaboratively in a team environment and be self‑starting and able to work independently.
Ability to effectively present recommendation/opinions in a group environment.
Fluency, both written and oral, in English.
Compensation and Benefits
The range described above is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
This job is eligible to participate in our long‑term incentive programs.
Equal Opportunity AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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