Safety Compliance Analyst

Safety Compliance Analyst

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 www.abbvie.com.

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:

• 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.

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

Recruitment Fraud Alert:

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• AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
• If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

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