Senior Manager, Pharmacovigilance Quality Assurance Audit
Company DescriptionAbbVie'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 DescriptionPurpose:
Describe the primary goals, objectives or functions or outputs of this position.
Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including
scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and
procedures wherever possible and leading the development and implementation of the PVQA quality
system. Provision of advice and support on PV and quality topics to business partners to ensure
compliance with worldwide PV requirements and expectations.Responsibilities:Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA oversight activities.Contributes to the delivery of innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions.Contributes to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies.Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.Contributes to the PV audit program by planning and, executing PV audits and working with auditees to resolve any non-compliance identified.Actively participates in and supports PV inspections onsite or remotely to ensure that PV inspections are a success and support resolution of findings by working with PV business partners.Promotes continuous education with regards to PV regulations and expectations for self and other AbbVie staff.Participates in the analysis of PV compliance data and emerging regulatory intelligence to demonstrate appropriate QA supervision of the compliance of the AbbVie PV system.This role can be remote in the United States.QualificationsBachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience5 years of experience in the biopharmaceutical industry or with a regulatory authority5 years of experience in Quality Assurance and/or PharmacovigilanceAn equivalent combination of education and experience may be accepted as a satisfactory substitute
for the specific experience listed above with a total of 10 years of experienceStrong analytical skills and the ability to organize work in a logical, through and succinct mannerUnderstanding of quality systems and auditing standardsKnowledge of PV regulatory requirements and industry best practicesFlexibility to adapt to changing assignments and ability to effectively prioritizeProject management, interpersonal, and communication skills and ability to work independentlyand as part of a teamWillingness and ability to perform international travel
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below 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 programsNote: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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 AbbVie’s 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
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Describe the primary goals, objectives or functions or outputs of this position.
Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including
scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and
procedures wherever possible and leading the development and implementation of the PVQA quality
system. Provision of advice and support on PV and quality topics to business partners to ensure
compliance with worldwide PV requirements and expectations.Responsibilities:Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA oversight activities.Contributes to the delivery of innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions.Contributes to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies.Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.Contributes to the PV audit program by planning and, executing PV audits and working with auditees to resolve any non-compliance identified.Actively participates in and supports PV inspections onsite or remotely to ensure that PV inspections are a success and support resolution of findings by working with PV business partners.Promotes continuous education with regards to PV regulations and expectations for self and other AbbVie staff.Participates in the analysis of PV compliance data and emerging regulatory intelligence to demonstrate appropriate QA supervision of the compliance of the AbbVie PV system.This role can be remote in the United States.QualificationsBachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience5 years of experience in the biopharmaceutical industry or with a regulatory authority5 years of experience in Quality Assurance and/or PharmacovigilanceAn equivalent combination of education and experience may be accepted as a satisfactory substitute
for the specific experience listed above with a total of 10 years of experienceStrong analytical skills and the ability to organize work in a logical, through and succinct mannerUnderstanding of quality systems and auditing standardsKnowledge of PV regulatory requirements and industry best practicesFlexibility to adapt to changing assignments and ability to effectively prioritizeProject management, interpersonal, and communication skills and ability to work independentlyand as part of a teamWillingness and ability to perform international travel
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below 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 programsNote: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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 AbbVie’s 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
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