Senior Manager, Pharmacovigilance Quality Assurance
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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.
- 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.
- Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience at least 8 years) with exposure to medicinal or combination product related industries.
- 10 years of experience in the biopharmaceutical industry or with a regulatory authority, including 6 + years in quality assurance and/or pharmacovigilance. Experience in compliance/auditing is desirable
Knowledge and thorough understanding of global Pharmacovigilance regulatory requirements and industry best practices and an understanding of the principles of quality management.
Strong analytical skills and the ability to organize work in a logical, through and succinct manner. Project management, interpersonal, and excellent communication skills. Flexibility to adapt to changing assignments and ability to effectively prioritize workload.
Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and in cross-functional teams.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 25 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.