Senior Manager, Pharmacovigilance Quality Assurance Audit

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

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 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.

Qualifications

Bachelors 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 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

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.

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