Safety Compliance Analyst

Job Description

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 :

Safety Compliance drives excellence in global pharmacovigilance (PV) quality standards and policy, through the establishment, maintenance and monitoring of the PV quality management system; providing the framework for the Global Patient Safety (GPS) organization to enable operational excellence in compliance with legal requirements worldwide and pragmatic risk-taking in PV policy decisions and process design.

The Safety Compliance Analyst is responsible to gather and analyse data to support robust decision making and evidence the state of compliance of the AbbVie PV system. This position will support the Safety Compliance Oversight and Improvement team leader in the execution of PV system oversight and change management activities.

Responsibilities :

Execute reviews of PV documents, systems and data to assess compliance with global regulations, guidelines and applicable Corporate policies and procedures; in so doing, support the delivery of regulatory preparedness for GxP regulation inspections and internal / external audits.

Administer GPS systems access and training controls. Maintain GPS systems inventory. Work with cross-functional business partners such as BTS, RDQA, Clinical Sciences Strategic Operations.

Execute Business System Owner (BSO) responsibilities for assigned GPS systems;  collaborate with applicable business leads across GPS to ensure full understanding of user requirements, system functionality, compliance risks, associated mitigations and relevance within the PV system.

Ensure robust and documented justification for compliance-related decisions.

Responsible for understanding AbbVie's Quality System and applying the knowledge when executing activities. Provides internal stakeholders with the understanding and practical application of AbbVie’s Quality System.

Identify issues that potentially impact compliance, quality, timelines for process improvement projects; propose potential interventions or solutions to manage the issues; fully engage in projects and initiatives to support the advancement of Safety Compliance processes.

Responsible for the retention of relevant compliance documentation and safety artifacts to ensure they are easily retrievable for audits and inspection purposes.

Other duties may be assigned based on the need or work requirement of the department deliverables

This role will be a hybrid role with onsite at our Lake County, IL headquarters.

Qualifications

Bachelor’s degree required, preferably in health, science, engineering or quality field

Regulated industry experience required, Pharmaceutical industry and / or PV experience preferred

Experience in measurement, analytics and data analysis

Knowledge of GxP quality systems principles or experience working in GxP environment preferred

Knowledge of IT system lifecycle management preferred

Demonstrated attention to detail, good documentation practices, and effective communication skills required.

Experience in analytics and data analysis to derive insights and drive decisions

Critical reasoning, problem-solving and decision-making abilities required

Additional Information

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. ​

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 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

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