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AbbVie
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.
Purpose:
The purpose of this role is to support Safety Compliance leadership to develop, implement, maintain and monitor an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization that at a minimum meets global regulatory legal requirements and standards, and additionally promotes best practice and excellence.
The role primarily supports all tasks associated with the implementation of the Pharmacovigilance (PV) Investigation / CAPA and Planned Deviation process within the Pharmacovigilance and Patient Safety (PPS) organization. Additionally, supporting audits/inspections impacting the PV system.
The scope extends to Pharmacovigilance (PV) activities worldwide and spans the life cycle of all products.
Responsibilities:
· Independently resolves routine issues. Handles complex problems by proposing potential solutions to management. Contributes to departmental policy.
· Review, develops, and monitors global pharmacovigilance compliance metrics.
· Leads the preparation and conduct of PV relevant, internal, and external global audit and inspection process, responses and develops associated improvement plans (e.g., EMA, MHRA, FDA; response to warning letters or USFDA 483s)
· Review and triage of reports of non-conformances and potential non-conformances using professional judgement and expertise
· Review and approve exception reports, planned deviations and CAPA tasks in line with internal and regulatory requirements.
· Review, evaluates and proposes necessary changes to regulatory guidance (e.g., ICH).
· Evaluates and develops appropriate work tools and methodologies to enable staff to continually improve performance and productivity
· Actively identify, propose, and implement improvements while fully engaging in new initiatives to continually support the advancement of the Audit/Inspection process, PV investigation/CAPA process and Planned Deviation process.
This role will have a hybrid schedule, with 3 days onsite at our Lake County Headquarters.
Applicable 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 programs
Note: 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
