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【R&D】Regional Associate Director Inspection Excellence, QPPV &PV Excellence, Patient Safety

Ort Ōsaka, Ōsaka-fu, Japan Kita-ku, Tokyo Prefecture, Japan Anzeigen-ID R-153721 Veröffentlichungsdatum 01/12/2022

■ Job Description / Capsule

Working with Compliance and Inspection Excellence (CIE) Leads in the QPPV&PV Excellence Team in Patient Safety, in Chief Medical Office (CMO), taking responsibility for the management of assigned AstraZeneca projects and partnerships including: continuous improvement; process updates; communication; quality and compliance.Accountable to develop relationships across CMO and other relevant AZ functions, with a focus on regional markets, to execute the delivery of the QPPV&PV Excellence strategy and priorities.

■ Typical Accountabilities

Responsibilities:

  • Drive a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches, across the AZ Pharmacovigilance (PV) system.

  • Identify and drive implementation of opportunities to improve and simplify processes and guidance.

  • Utilise knowledge of pharmacovigilance and associated regulatory and drug development processes to maintain and support the global inspection excellence strategy.

  • Lead coordination activities for GVP, GCP and GMP audits/inspections both globally and with local affiliates.

  • Working across Patient Safety, identify issues and risks and propose options to mitigate them.

  • Working across Patient Safety, coach CAPA owners to develop effective Root Cause Analysis and CAPA.

  • Provide training to Patient Safety and other functional groups in key areas of expertise.

  • Participate in development and implementation of strategic outsourcing activities.

  • Provide support to outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintain inspection readiness.

  • Contribute to communication and change management activities associated with Patient Safety initiatives.

  • Manage relationships/partnerships/alliances external to Patient Safety that are essential to delivering AstraZeneca’s pharmacovigilance License To Operate responsibilities, e.g. across AstraZeneca affiliates.

  • Working collaboratively, provide expertise and sharing best practices across all regions and in all partnerships.

  • Deliver on project assignments supporting the business, e.g. representation or leadership on global cross-functional task forces.

  • Monitor, interpret and validate current, new and changing legislation. Manage the impact of changes and provide compliance support to Patient Safety teams.

  • Seek personal and professional development opportunities and share knowledge gained in open forums.

  • May represent AZ on industry bodies.  

  • Serve as the delegate, where appropriate, for the Inspection Excellence Lead.

  • Ensure that appropriate, up-to-date records are maintained for compliance.

Education, Qualifications, Skills and Experience

Essential

  • A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)

  • Proven ability to work cross-functionally, across cultures and time zones in a virtual/remote environment

  • Leadership skills, including experience of  leading project teams

  • Thorough scientific knowledge sufficient to understand all aspects pharmacovigilance issues 

  • Thorough knowledge of the drug development process

  • Problem solving and negotiations skills

  • Good attention to detail

  • Excellent written and verbal communication skills

Desirable

  • MSc/PhD in scientific discipline

  • Knowledge of new and developing pharmacovigilance requirements/expectations

  • Knowledge of existing AstraZeneca external alliances and collaborative projects

  • Experience of working with third party suppliers

  • Experience of working in a global organisation, preferably within the pharmaceuticals industry

  • Knowledge of QMS and continuous improvement methodologies

  • Ability to lead change without authority

Key Relationships to reach solutions

Internal (to AZ or team)

  • Global PS including Marketing Companies

  • Other CMO functions

  • Development functions

  • IS/IT

External (to AZ)

  • External professional and regulatory organizations

  • Regulatory Authorities

  • External Partners

  • Suppliers

■キャリアレベル / Career Level

E

■勤務地 / Work Location



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 authorisation and employment eligibility verification requirements.

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