Job description
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
Purpose: 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 AbbVie quality system. Leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. 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 regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA consultation activities.
· Lead PV audits (internal system and/or process, affiliates and third parties) to ensure compliance to global regulatory and AbbVie requirements. Effectively communicate audit results, both orally and in writing.
· Assimilates audit observations and compilation of PV audit reports and reviews and approves 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.
· 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 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.
· Leadership of PV Internal Audit SME role supporting PV inspections and License Partner audits of AbbVie onsite or remotely to ensure that PV inspections are a success.
· Promotes 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, through 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
