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Overview
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 key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, visit www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.
Job Description Purpose:
Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensure alignment with RDQA policies and procedures wherever possible and lead the development and implementation of the AbbVie quality system. Provide leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provide advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.
Responsibilities:
Assure quality and compliance in a regulated environment that includes worldwide regulations, country-specific and other applicable standards and AbbVie policies and procedures by continuously evaluating PV processes through audit and QA consultation activities.
Lead PV audits (internal system and/or process, affiliates and third parties) to ensure compliance with global regulatory and AbbVie requirements. Effectively communicate audit results, both orally and in writing.
Assimilate audit observations and compile PV audit reports; review and approve Corrective Action Plans submitted in response to audit observations within target timeframes. Track actions through to completion.
Assist in the design, planning and execution of risk-based methodologies to inform the annual PVQA audit plan.
Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.
Contribute to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies.
Provide critical audit related data, updates and scheduling content to assure accurate maintenance and reporting of the Product Safety Master File (PSMF) globally.
Lead PV Internal Audit SME role supporting PV inspections and License Partner audits of AbbVie onsite or remotely to ensure that PV inspections are successful.
Promote continuous education with regards to PV regulations for self and other AbbVie staff. Support team members in their development and training.
This role can be remote within the US or the UK.
Qualifications
Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience.
5 years of experience in the biopharmaceutical industry or with a regulatory authority.
5 – 7 years of experience in Quality Assurance and/or Pharmacovigilance.
An 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 experience.
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Understanding of quality systems and auditing standards.
Knowledge of PV regulatory requirements and industry best practices.
Flexibility to adapt to changing assignments and ability to effectively prioritize.
Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
Willingness and ability to perform international travel.
Additional Information 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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Job Description Purpose:
Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensure alignment with RDQA policies and procedures wherever possible and lead the development and implementation of the AbbVie quality system. Provide leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provide advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.
Responsibilities:
Assure quality and compliance in a regulated environment that includes worldwide regulations, country-specific and other applicable standards and AbbVie policies and procedures by continuously evaluating PV processes through audit and QA consultation activities.
Lead PV audits (internal system and/or process, affiliates and third parties) to ensure compliance with global regulatory and AbbVie requirements. Effectively communicate audit results, both orally and in writing.
Assimilate audit observations and compile PV audit reports; review and approve Corrective Action Plans submitted in response to audit observations within target timeframes. Track actions through to completion.
Assist in the design, planning and execution of risk-based methodologies to inform the annual PVQA audit plan.
Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.
Contribute to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies.
Provide critical audit related data, updates and scheduling content to assure accurate maintenance and reporting of the Product Safety Master File (PSMF) globally.
Lead PV Internal Audit SME role supporting PV inspections and License Partner audits of AbbVie onsite or remotely to ensure that PV inspections are successful.
Promote continuous education with regards to PV regulations for self and other AbbVie staff. Support team members in their development and training.
This role can be remote within the US or the UK.
Qualifications
Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience.
5 years of experience in the biopharmaceutical industry or with a regulatory authority.
5 – 7 years of experience in Quality Assurance and/or Pharmacovigilance.
An 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 experience.
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Understanding of quality systems and auditing standards.
Knowledge of PV regulatory requirements and industry best practices.
Flexibility to adapt to changing assignments and ability to effectively prioritize.
Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
Willingness and ability to perform international travel.
Additional Information 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
#J-18808-Ljbffr