Associate Medical Director, Medical Quality Assurance
Apply NowCompany: BioSpace
Location: North Chicago, IL 60064
Description:
Job Details
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 . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
The Medical Quality Assurance Physician plays a critical role in ensuring patient safety and product effectiveness within a pharmaceutical setting. This multifaceted position involves collaboration with the Product Safety Team to author and approve Health Hazard Assessments and Medical Opinions concerning potential product-related issues. The Medical Quality Assurance Physician is essential for maintaining high standards of product quality and safety, protecting patient well-being across all stages of product lifecycles.
Major Responsibilities:
Design of product life cycle strategy, where key Quality System areas are underpinned by medical knowledge commensurate with the potential risk to patient safety e.g. risk assessment, manufacturing / distribution events, product complaints & product discontinuation
Support the development and maintenance of device / combination products (e.g.- Design History Files, Risk Management Files , product benefit-risk assessments)
Support the design of product-use risk assessment tools, ensuring that the product risk/benefit profile for HCP/patient usage is appropriate
Review of significant product changes, including specification changes, ensuring appropriate assessment of the proposed changes on patient safety
Support the design of robust alert and action thresholds for product complaints, to enable effective signal monitoring, detection and action
Review and approval of appropriate product complaints providing medical assessment of the potential risk to patient safety
Review and approval of appropriate product labelling issues providing medical assessment of the potential risk to patient safety partnership, to support potential product related issues
Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global Medical Affairs (GMA) and Clinical Development on high impact quality issues potentially affecting product safety & efficacy, including supporting construction of DHCP communications
Review and approval of appropriate manufacturing / distribution events providing medical assessment of the potential risk to patient safety (Member of Triage Committee)
Approval of Health Hazard Assessments & Medical Opinions, with Product Safety Team
Qualifications
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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
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 . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
The Medical Quality Assurance Physician plays a critical role in ensuring patient safety and product effectiveness within a pharmaceutical setting. This multifaceted position involves collaboration with the Product Safety Team to author and approve Health Hazard Assessments and Medical Opinions concerning potential product-related issues. The Medical Quality Assurance Physician is essential for maintaining high standards of product quality and safety, protecting patient well-being across all stages of product lifecycles.
Major Responsibilities:
Design of product life cycle strategy, where key Quality System areas are underpinned by medical knowledge commensurate with the potential risk to patient safety e.g. risk assessment, manufacturing / distribution events, product complaints & product discontinuation
Support the development and maintenance of device / combination products (e.g.- Design History Files, Risk Management Files , product benefit-risk assessments)
Support the design of product-use risk assessment tools, ensuring that the product risk/benefit profile for HCP/patient usage is appropriate
Review of significant product changes, including specification changes, ensuring appropriate assessment of the proposed changes on patient safety
Support the design of robust alert and action thresholds for product complaints, to enable effective signal monitoring, detection and action
Review and approval of appropriate product complaints providing medical assessment of the potential risk to patient safety
Review and approval of appropriate product labelling issues providing medical assessment of the potential risk to patient safety partnership, to support potential product related issues
Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global Medical Affairs (GMA) and Clinical Development on high impact quality issues potentially affecting product safety & efficacy, including supporting construction of DHCP communications
Review and approval of appropriate manufacturing / distribution events providing medical assessment of the potential risk to patient safety (Member of Triage Committee)
Approval of Health Hazard Assessments & Medical Opinions, with Product Safety Team
Qualifications
- Minimum: M.D. or equivalent (D.O., M.B.B.S, etc.)
- Board certification preferred, however a variety of clinical experiences are well-suited for this position
- 0-5 years of experience in drug risk management and/or medical device/ combination product vigilance (safety signal detection, data mining techniques, pharmacovigilance / device vigilance databases, etc.)
- Track record of successful management of product safety matters preferred
- Experience in the clinical and medical device development process in a global medical device company and preparation risk management plans, aggregate reports and company core safety information highly desirable
- Basic clinical, drug and/or medical device development expertise
- Good organizational and prioritization skills
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
- This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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