At a Glance
- Tasks: Lead safety compliance initiatives and oversee quality management systems in a dynamic pharmaceutical environment.
- Company: AbbVie is dedicated to innovating medicines that tackle serious health challenges and improve lives globally.
- Benefits: Enjoy a full-time role with opportunities for career development, teamwork, and a culture of innovation.
- Why this job: Make a significant impact on patient safety while working in a collaborative and inclusive environment.
- Qualifications: Bachelor’s degree in a relevant field; experience in quality system management and compliance required.
- Other info: Join a company committed to integrity, diversity, and transforming lives through innovative healthcare solutions.
The predicted salary is between 43200 - 72000 £ per year.
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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 Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
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 Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik 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 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 AbbVie’s 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
- 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 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:
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
-
Job function
Legal
-
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Safety Compliance Director employer: AbbVie
Contact Detail:
AbbVie Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Safety Compliance Director
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those involved in safety compliance and pharmacovigilance. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with AbbVie's mission and values, as well as their current projects and initiatives. This knowledge will help you align your discussions and demonstrate how your experience can contribute to their goals during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led cross-functional teams and managed compliance risks in previous roles. Highlight your strategic thinking and ability to influence senior management, as these are key qualities for the Safety Compliance Director position.
✨Tip Number 4
Stay updated on global regulatory changes and compliance standards relevant to pharmacovigilance. Being knowledgeable about ICH, FDA, and EMA regulations will not only boost your confidence but also show your commitment to the role and the industry.
We think you need these skills to ace Safety Compliance Director
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Safety Compliance Director position at AbbVie. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in Quality System Management and any relevant pharmaceutical industry experience. Use specific examples that demonstrate your ability to lead cross-functional teams and manage compliance risks.
Showcase Leadership Skills: Since this role requires strong leadership presence, be sure to highlight your leadership experiences. Discuss how you've successfully influenced senior management and led teams through complex projects.
Tailor Your Application: Customise your CV and cover letter to reflect AbbVie's mission and values. Mention how your personal goals align with their commitment to innovation and improving lives, which will show your genuine interest in the company.
How to prepare for a job interview at AbbVie
✨Understand the Regulatory Landscape
Familiarise yourself with global regulatory requirements and standards relevant to pharmacovigilance and patient safety. Being able to discuss ICH, FDA, and EMA regulations will demonstrate your expertise and readiness for the role.
✨Showcase Leadership Experience
Prepare examples of your past leadership roles, particularly in managing cross-functional teams. Highlight how you have successfully navigated complex projects and influenced senior management to achieve compliance goals.
✨Emphasise Strategic Thinking
Be ready to discuss your approach to strategic planning and risk management. Share specific instances where you identified potential compliance risks and implemented effective mitigation strategies.
✨Build Relationships
Demonstrate your ability to build strong partnerships with internal stakeholders. Discuss how you have leveraged these relationships to advance organisational goals and foster a culture of compliance and innovation.