Safety Compliance Director
Safety Compliance Director
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1 Vacancy
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 vision and 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 that have vigilance-related impact to PPS and AbbVie. Provide strategic advice to stakeholders to achieve compliant processes and solutions
- Lead PPS strategy for PV system compliance oversight including significant changes to the PV system and associated GxP change management
- Accountable for driving analysis impact assessment and change planning including risk identification and mitigations action plans trending and effectiveness assessments
- Accountable for the creation and maintenance of the Global PV system performance and compliance metrics framework
- Create flexible and resilient processes where organizational and business changes are managed effectively; delegate effectively 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 Compliance Management team
- Perform leadership activities to include hiring onboarding coaching performance reviews andcareer development to maximize potential of reporting team. Provide leadership that fosters AbbVies talent philosophy while creating and driving transparency with teamwork dynamics providing a highly motivating and innovation culture through inclusion while leading with excellence and integrity
Qualifications :
- Bachelors 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 and compliance 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 make and 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 including functional 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 visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Full-time
Employment Type
Remote
