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Senior director, Patient Safety Compliance Excellence

AstraZeneca
Posted 3 months ago, valid for 19 days
Location

Gaithersburg, Montgomery 20898, MD

Salary

$197,318 - $295,978 per hour

Contract type

Full Time

Paid Time Off

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Sonic Summary

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  • The Senior Director, Pharmacovigilance Compliance is a leadership role within Patient Safety, focusing on global compliance governance and continuous improvement in pharmacovigilance.
  • Candidates must have a Bachelor's degree in a scientific or healthcare discipline and at least 10 years of experience in pharmacovigilance, regulatory compliance, or patient safety.
  • The position involves driving strategic compliance initiatives, developing policies, and utilizing analytics to enhance compliance frameworks.
  • The annual base salary for this role ranges from $197,318.40 to $295,977.60, with additional incentives and comprehensive benefits.
  • AstraZeneca is committed to diversity and inclusivity, welcoming applications from all qualified candidates regardless of their backgrounds.

The Senior Director, Pharmacovigilance Compliance is a criticalleadership rolewithin Patient Safety, responsible for the global governance and continuous improvement of compliance controls across the AstraZeneca pharmacovigilance landscape. The role drives both strategic and operational compliance by implementing robust predictive and detective controls, fostering an enterprise-wide safety and compliance culture and shaping policy. Key elements include championing the use of analytics, innovating compliance frameworks, developing compliance policies and standards, and partnering with QPPV to ensure optimal compliance and readiness globally through prediction and early detection. 

Typical Accountabilities 

  • Accountable for the global pharmacovigilance compliance model, encompassing preventive, detective, and corrective controls. 

  • Leads innovation in predictive compliance using advanced analytics and digital platforms to proactively identify and manage risks. 

  • Develops and maintains detective monitoring frameworks, including dashboards,that cover quality issues, audit findings, and root cause analysis information. 

  • Promotes and supports the development of global PV policies/procedures ensuring international alignment and regulatory compliance.  

  • Drives timely and sustainable preventive and corrective actions, embedding improvements into compliance frameworks and governance. 

  • Maintains compliance governance models and ensures effective engagement in governance meetings, such as PV council.  

  • Sponsors safety and compliance culture across Patient Safety; supports training, communication, and best/global standard practice dissemination. 

  • Partners closely with Inspection Excellence to ensure integrated compliance and inspection readiness approaches. 

  • Represents Patient Safety externally with regulators and in professional forums; ensures continual advocacy and knowledge leadership. 

  • Develops and mentors a high-performing, globally distributed team, championing talent and professional development. 

  • Provides comprehensive compliance reporting and strategic recommendations to QPPV/senior leadership. 

Essential 

  • Bachelor's degree (or equivalent) in a scientific/healthcare discipline 
  • 10+ years experience in pharmacovigilance, regulatory compliance, patient safety 
  • Demonstrated global QA and compliance leadership 
  • Thorough knowledge of directive, preventive, detective, and corrective controls 
  • Proven digital compliance/predictive analytics track record 
  • Cross-functional global experience (matrix working) 
  • Strong US/global compliance environment experience 
  • Excellence in communication, advocacy, and talent development 

Desirable 

  • PhD or equivalent in scientific discipline 
  • Extensive experience in pharmacovigilance, regulatory compliance, patient safety 
  • Experience with digital transformation, Lean/process improvement 
  • Demonstrated global QA and compliance leadership 
  • Financial awareness/oversight 
  • Thorough knowledge of directive, preventive, detective, and corrective controls 
  • Familiarity with new/emerging regulatory requirements 
  • Proven digital compliance/predictive analytics track record 
  • Experience with external engagement (industry, regulators) 
  • Cross-functional global experience (matrix working) 
  • Strong US/global compliance environment experience 
  • Excellence in communication, advocacy, and talent development 

Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours. Apply today.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.


 

The annual base pay (or hourly rate of compensation) for this position ranges from $197,318.40 - $295,977.60 . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.




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