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Associate Director, Patient Safety Excellence

Location: Barcelona, Spain (on-site) 3 days working from the office / 2 days working from home

  • Act as QPPV Pharmacovigilance (PV) Expert, continually strengthen QPPV oversight of the pharmacovigilance system, reach and influence internally and externally, thus driving gold standard pharmacovigilance quality, compliance and efficiency for AstraZeneca.
  • In support of PV Excellence, manage and oversee QPPV Office deliverables; for example Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS), AstraZeneca profile in EudraVigilance and PRAC output monitoring,
  • Contribute to continuous improvement projects relevant to the scope of the QPPV function. 

Typical Accountabilities

  • Deliver according to the QPPV Office Operating Model to ensure PV System Quality and Compliance and strengthen QPPV oversight and influence. This includes, but is not limited to, the following activities:
     
    • Coordinate, manage and drive the review and update of the Pharmacovigilance System Master File (PSMF)
    • Triage and handling of PSMF & PRAC oversight related matters requiring QPPV input and/or awareness.
    • Monitor PRAC outputs as per SOP and guidelines. 
    • Develop standardised best practice, templates, authoring,  instructions and guidance for production of Patient Safety outputs in relation to e.g., PSMF.
    • As relevant interpret and validate current, new and changing legislation and contribute to interpretation and impact analysis 
    • Contribute to the EU QPPV’s management and oversight of the PV Quality System.  
    • Coordination and ownership of the lifecycle management of nominated processes (for example; EU QPPV Standard and PSMF and SPS Standard Operating Procedure (SOP).
    • Maintain and improve, as relevant, reporting tools and analysis processes to facilitate pharmacovigilance oversight.
    • Provide process training to CMO staff and other functional groups, including the PSMF Coordinator back up, as necessary.
    • Coordinate and manage AstraZeneca’s profile in EudraVigilance, including oversight of user access (Trusted Deputy role).
    • Provide specialist knowledge and support to be recognised as an expert and source of reference for safety teams and other stakeholders.
    • Upon request participate in and/or support activities for GVP audits/inspections.
    • Undertake other nominated tasks as requested; for example contribution to and coordination of projects led by the QPPV Office
    • Work collaboratively with other skill groups or functions to ensure alignment of activities and priorities, sharing of best practices, etc.
    • Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
    • Seek personal and professional development opportunities, and share knowledge gained

Education, Qualifications, Skills and Experience

Essential

  • Life science degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in life sciences, or related field
  • Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
  • Extensive operational experience in production of core safety outputs
  • Good knowledge and comprehension of relevant pharmacovigilance legislation
  • Excellent medical writing skills
  • Excellent communication skills
  • Experience and ability to develop and implement new standards and best practices
  • Project management skills
  • Proven ability to lead teams and collaborate in a continuous improvement
  • Strategic thinking capability
  • Good knowledge of the AZ organization
     

Desirable

  • Regulatory strategy knowledge and experience
  • Clinical development knowledge and experience
  • Lean Sigma experience

Date Posted

28-mar-2025

Closing Date

27-mar-2025

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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Average salary estimate

$100000 / YEARLY (est.)
min
max
$80000K
$120000K

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What You Should Know About Associate Director, Patient Safety Excellence, AstraZeneca

Are you looking to make a meaningful impact in the field of pharmacovigilance? Join AstraZeneca as an Associate Director of Patient Safety Excellence in the beautiful city of Barcelona, Spain! This on-site role offers a fantastic balance, with 3 days a week working from the office and 2 days from home. As the QPPV Pharmacovigilance (PV) Expert, you'll be integral in enhancing the quality, compliance, and efficiency of our pharmacovigilance systems. Your leadership will drive our QPPV Office deliverables, manage the Pharmacovigilance System Master File, and influence best practices across the organization. You'll coordinate essential activities, contribute to continuous improvement projects, and provide specialist knowledge that will support safety teams and stakeholders. Your role will involve the interpretation and validation of legislation, providing training to staff, and actively participating in audits and inspections. We're looking for someone with a life sciences background, extensive experience in patient safety, and a strong understanding of pharmacovigilance legislation. If you're eager to collaborate with talented teams, seek continuous improvement, and uphold a culture of quality and innovation, we want to hear from you! Your growth matters to us, and we'll ensure you have personal and professional development opportunities. Join us in building an inclusive and diverse team committed to excellence.

Frequently Asked Questions (FAQs) for Associate Director, Patient Safety Excellence Role at AstraZeneca
What are the main responsibilities of the Associate Director, Patient Safety Excellence at AstraZeneca?

The Associate Director, Patient Safety Excellence at AstraZeneca is responsible for overseeing QPPV Office deliverables, managing the Pharmacovigilance System Master File, and ensuring compliance and quality in pharmacovigilance processes. This role includes monitoring PRAC outputs, driving continuous improvement projects, and providing training and support to staff in pharmacovigilance practices.

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What qualifications are required for the Associate Director, Patient Safety Excellence position at AstraZeneca?

To qualify for the Associate Director, Patient Safety Excellence at AstraZeneca, candidates must possess a life sciences degree (MD, PharmD, RN, etc.) or a higher degree in life sciences. Extensive experience in patient safety and pharmacovigilance along with proficient medical writing skills and project management capabilities are essential. Strong communication skills and the ability to develop best practices are also important.

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How does the work environment look for the Associate Director, Patient Safety Excellence at AstraZeneca?

The work environment for the Associate Director, Patient Safety Excellence at AstraZeneca in Barcelona combines both office and remote work. With 3 days in the office and 2 days at home, it promotes a healthy work-life balance while allowing for effective collaboration within the team.

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How does the Associate Director, Patient Safety Excellence contribute to ongoing projects at AstraZeneca?

In their role, the Associate Director, Patient Safety Excellence at AstraZeneca contributes to various ongoing projects by coordinating and managing critical processes related to pharmacovigilance, enhancing quality standards, and participating in the development of new strategies and practices. They also participate in audits and support the training of other team members.

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What opportunities for growth exist for the Associate Director, Patient Safety Excellence at AstraZeneca?

The Associate Director, Patient Safety Excellence at AstraZeneca enjoys numerous growth opportunities through personal and professional development. The company emphasizes continuous improvement and supports team members in seeking opportunities to enhance their skills, whether through workshops, additional training, or mentorship.

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Common Interview Questions for Associate Director, Patient Safety Excellence
Can you explain your experience with pharmacovigilance systems in relation to the Associate Director position?

In your response, highlight your extensive experience working with pharmacovigilance systems, detailing how you've managed or contributed to system master files or compliance processes in past roles. Illustrate how your efforts led to enhanced quality and efficiency.

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What strategies do you suggest for improving pharmacovigilance quality in an organization?

When answering, discuss specific strategies you have implemented successfully in prior roles, focusing on how you've driven continuous improvement, established best practices, and fostered a culture of quality and compliance among teams.

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How do you handle changes in pharmacovigilance legislation?

You should explain how you stay updated with current regulations, how you analyze their impact on your organization's processes, and provide examples of how you've successfully implemented changes to comply with new legislation in your past positions.

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Describe your experience with project management in the context of patient safety.

In your answer, detail specific projects you've managed related to patient safety, highlighting your role, the challenges faced, outcomes achieved, and how you collaborated with various stakeholders to ensure project success.

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What role do you see training playing in pharmacovigilance systems?

Discuss how critical training is for maintaining compliance and quality in pharmacovigilance. You can emphasize experiences where you organized or conducted training sessions and the feedback or results that demonstrated its importance.

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How do you approach collaboration with cross-functional teams?

Share your strategies for effective collaboration, including communication techniques, methods for aligning goals, and any experience you have that showcases your ability to work across different teams or departments successfully.

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What measures would you take to ensure compliance within your team?

Focus on the assessment and implementation of compliance programs, monitoring outputs, providing regular trainings, and fostering an open culture for discussing compliance challenges and resolutions among team members.

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How do you prioritize tasks when managing multiple projects in pharmacovigilance?

Outline your time management strategies, including tools you use, methods for assessing urgency versus importance, and examples of how prioritization has led to successful project outcomes in past employment.

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Can you discuss your experience with EudraVigilance?

Explain your involvement with EudraVigilance, discussing how you've managed profiles, supported user access, or overseen related oversight. Also, mention the significance of maintaining accurate profiles and the implications for compliance.

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What motivates you in the field of patient safety?

Share your personal motivations, whether it's a commitment to patient care, the challenge of navigating regulations or the satisfaction of improving safety outcomes. Tailor this to showcase your alignment with AstraZeneca's values and mission.

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AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We’re consta...

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DATE POSTED
March 29, 2025

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