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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
Job Overview
The purpose of this role is to provide leadership within the Safety Compliance organization to develop,
implement, maintain and monitor an optimized Quality Management System for the
Pharmacovigilance and Patient Safety (PPS) organization and Affiliate Safety Staff, that at a minimum
meets global regulatory legal requirements and standards. The scope extends to Pharmacovigilance
(PV) activities worldwide and spans the life cycle of all products. As Director, Safety Compliance, this is
a highly visible role that provides oversight, leadership and strategic direction to the PPS organization,
specifically in relation to PV system oversight and change management.
Key Responsibilities
* Build strong strategic partnerships with key internal stakeholders across Clinical Sciences, the broader R&D organisation
* Leverage relationships to advance organizational goals and priorities. Translate departmental visionand strategy into actionable strategic priorities for the Safety Compliance: Compliance Oversight team, and oversee implementation
* Lead complex, high impact, priority cross-functional/global compliance activities and initiatives thathave vigilance-related impact to PPS and AbbVie. Provide strategic advice to stakeholders to achievecompliant processes and solutions
* Lead PPS strategy for PV system compliance oversight, including significant changes to the PV systemand associated GxP change management
* Accountable for driving analysis, impact assessment and change planning, including riskidentification and mitigations, action plans, trending and effectiveness assessments
* Accountable for the creation and maintenance of the Global PV system performance and compliancemetrics framework
* Create flexible and resilient processes where organizational and business changes are managed effectively; delegateeffectively with oversight to empower; establish a climate to ensure that effective decisions are made
* Deliver regional strategy execution for audits and inspections, in alignment with Safety ComplianceManagement team
* Perform leadership activities to include hiring, onboarding, coaching, performance reviews andcareer development to maximize potential of reporting team. Provide leadership that fosters AbbVie’stalent philosophy while creating and driving transparency with teamwork dynamics, providing a highlymotivating and innovation culture through inclusion, while leading with excellence and integrity
Qualifications
* Bachelor’s Degree in Science, Health Related, or Quality field. Advanced Degree preferred or equivalent experience
* Pharmaceutical industry experience within Quality System Management i a global scope
* Knowledge of Quality Systems and global vigilance compliance requirements (e.g. ICH, FDA,EMA) including regulations and standards affecting pharmaceutical products, biologics and devices
* Proven ability to proactively identify, rapidly assess, and effectively manage & mitigate business andcompliance risks
* Significant experience leading cross-functional teams on complex projects. Advanced influencing skills. Ability to manage complex issues and distil information. Demonstrates the willingness to makeand accept unpopular decisions or take opposing positions. Strategic thinker
* Strong leadership presence and demonstrated ability in courageously challenging the status quo and influencing others. Experience in working directly with and influencing senior management includingfunctional heads
Additional Information
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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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https://www.abbvie.com/join-us/reasonable-accommodations.html
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