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Senior Director, Head of Global Patient Safety Systems, Gaithersburg, Maryland

CategoryR&D Oncology (Pascal Soriot (08126850) (Inherited)) (85008610)
Job typeFull Time
CountryUnited States
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

As the Senior Director, Head of Global Patient Safety Systems, you will beaccountable for the Global Patient Safety Systems and line management of a 10+ patient safety (PS) team members with expertise in different system areas. This role will apply a longstanding experience in Pharmacovigilance Systems to develop and implement the state-of-the-art PS Systems strategy involving innovative technology solutions including automation and artificial intelligence to build maximum competitive advantage. You will develop strategic relationships at the highest levels, identifying ways for PS, IT, and data sciences to partner achieving and exceeding PS objectives. This position influences the shaping of the organization by providing strategic direction, applying a full understanding of global issues related to the entire PS Organization.

Main Responsibilities:
  • Establishes vision and provides strategic direction to the global Patient Safety (Pharmacovigilance and Safety Surveillance) Systems group such that it is capable of delivering a high quality service to partners within and outside of the Chief Medical Office (CMO) organization, which meets or exceeds agreed goals/objectives.
  • Defining the automation strategy to increase efficiencies in the PS Systems
  • Accountable for an information and systems strategy for Patient Safety which remains aligned with overall global strategic priorities and the prioritized needs of the PS organization, its customers and partners.
  • Ensuring that internal, external, and technological drivers and trends are anticipated & incorporated into the evolving PS Systems strategy.
  • Ensuring interfaces with PS Systems partners/suppliers, are effectively managed
  • Certifying that critical systems and related information services are delivered by all PS Systems at all times; All PS-related Systems encompass:
    • Enterprise-wide pharmacovigilance compliance systems (e.g. SAPPHIRE, JASPER, NG-SMS, etc.)
    • Reporting tools from the global Patient Safety systems (e.g. Business Objects etc)
    • Data bridges into and from the global Patient Safety systems (e.g. RSG etc)
    • Information management and sharing solutions to support PS requirements.
    • Responsible for the development of the leadership and talent pipeline for the assigned areas of global accountability
  • Responsible for providing oversight and governance across the overall PS information and systems landscape.
  • Responsible for ensuring that overall demand for improvement and maintenance of PS Systems is prospectively identified, appropriately prioritized, and subsequently fed into the wider IT Long Range Plan (LRP).
  • Fosters a culture within PS Systems group which promotes integrity and compliance with all CoE /AZ policies and procedures.

Minimum Requirements:
  • MS degree in Healthcare, life sciences, information sciences or similar field; or equivalent experience in the pharmaceutical industry.
  • 5+ years Patient Safety, Regulatory and/or broader pharmaceutical experience, including involvement in the successful design and delivery migration, integration of PS Systems that generated business benefit.
  • Proven record of successful scientific innovation including automation and PS Systems uplift
  • Experience with change management within a global organization
  • 5+ years of experience leading Pharmacovigilance systems or equivalent group for a major bio-pharmaceutical company
  • 5+ years of Line Management experience in diverse, geographical locations globally
  • Proven track record in defining a vision and crafting strategic direction for a team, project or portfolio
  • Solid understanding of safety activities required to support drug development and marketed brands, including an understanding of regulatory safety obligations, pharmacovigilance practices and an awareness of ongoing developments relating to scientific safety activities in support of relevant TA projects.
  • Broad knowledge of the policies, processes and standards governing the submission and exchange of electronic information with regulatory authorities worldwide, and experience of implementing these effectively across a company.

  • Higher degree in a scientific or business subject area
  • Experience of exploiting scientific information in the context of pharmaceutical drug development.

  • Ability to acquire and assimilate knowledge in different fields and business areas.
  • Eye for business, with a sound understanding of portfolio governance, program management and investment approaches.
  • Excellent influencing, negotiating and communication skills with the ability to manage relationships with multiple partners, including at senior levels.
  • Strong collaborative, partnering, and interpersonal skills.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them

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