Associate Director, Patient Safety Digital

hace 4 semanas

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona, Spain (on-site)**

The Associate Director, Patient Safety Device & Digital contributes to the Patient Safety In-Vitro Diagnostic Device process area. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.

The Associate Director, Patient Safety Device & Digital responsibilities includes but is not limited to providing support to the In-Vitro Diagnostic Device process area including implementation, communication, compliance, performance and inspection readiness within Patient Safety.

**Typical Accountabilities***
- Responsible for the lifecycle management assigned Patient Safety processes related to diagnostic safety.
- Demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/partner engagement.
- Support the oversight of in-vitro diagnostic regulations and local requirements that impact Patient Safety and/or require implementation
- Serve as the delegate, where appropriate, for the Director, Device & Digital Safety
- Support the other process areas within Device & Digital Safety, including but not limited to Medical Devices and Digital Health.
- Support the allocation of and contribution to consultation requests regarding diagnostics
- Partner with License Agreement & Contracts where diagnostics are involved
- Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.
- Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant partners to improve processes.
- Accountable for being a great partner with supplier(s) providing all external services to the group as appropriate.
- Partner with system counterparts to ensure an integrated and holistic approach to processes and systems.
- Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers
- Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance
- Participate in projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross-functional teams.
- In partnership with peers (Other Nominated Area Leads) establish, champion and facilitate a top tier partnership relationship with the outsource provider. Includes championing relationship with internal AZ partners and forging strong partnership with all customers/partners. Ensures that all internal and external relationships and interfaces are handled effectively.
- Support AZ compliance with diagnostic regulatory and legal requirements, including implementation of new regulatory & legal requirements

**Education, Qualifications, **Skills** and Experience**

**Essential**
- University degree or equivalent qualification in relevant scientific field, with relevant experience
- two years, Post Graduate
- three years, Bachelors
- At least two year’s professional experience in patient safety, regulatory affairs or in quality management systems relating to diagnostics
- Knowledge and understanding of global diagnostic requirements, with a focus on the EU Invitro Diagnostic Regulation, and an ability to balance this with industry standards to achieve business goals
- Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role.
- Experience from authoring standards documents (Standard Operating procedures)
- Experience from development and provision of training through virtual meetings and other media
- Experience in outsourcing and partnership with external vendors
- Knowledge in project management skills, specifically leading teams
- Demonstrated excellent skills in: written and verbal communication
- Able to work with a high degree of autonomy
- Able to represent AstraZeneca externally where required
- Key capabilities:

- Understanding of governance processes
- Process improvement (e.g. Lean methodology)
- Collaboration/co-ordination
- Ability to influence without authority
- Open to multiple perspectives
- Balanced perspective
- Solution-focused
- Experience with inspection activities

**Desirable**
- University degree or equivalent qualification in relevant scientific field, with at least five years relevant experience
- PhD in scientific field
- Knowledge of new and developing regulatory and pharmacovigilance expectations

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