Associate Director, PS Operations, Technology & Analytics

AstraZeneca UK

Location: Cambridgeshire, Cheshire East, Gaithersburg, Maryland

Job Type: Full time

Posted

Perfection not required
Excited about this role, but not sure if you meet 100% of the criteria? Employers would still love to hear from you.

Do you have knowledge in regulatory/pharmacovigilance and partnership issues ? Do you have a “can do” attitude and an innovative approach and want to contribute to ensure good relationships across Patient Safety and related functions within Astra Zeneca and Alexion? Then this unique role with a broad spectrum of responsibilities might be the one for you!

At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Ensuring AstraZeneca comply with Pharmacovigilance regulations is key and in our team we make sure to make this a reality.

To meet our business priorities and address resource demands, we are now looking for you who wants to join our Global PS Operations, Technology & Analytics group in Patient Safety, CMO as an Associate Director in the ICSR team.

We are responsible for the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, compliance, performance, vendor oversight and inspection readiness within the ICSR area. We ensure good relationships across Patient Safety in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships

What you’ll do
As an Associate Director you will be working with Directors and Associate Directors in PV Processes, Partnerships and Contracts area, taking responsibility for the management of ICSR process and vendor oversight in AstraZeneca/Alexion, covering processes and partnerships including implementation, communication, compliance, performance and inspection readiness. You will be accountable to develop relationships across Patient Safety in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.

Here you will have a great opportunity to use your deep understanding of regulatory and pharmacovigilance processes and regulations providing process or compliance support to safety and regulatory teams and submissions as well as to develop and maintain a vision and strategy for nominated pharmacovigilance or regulatory processes. In addition you will:

  • Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment

  • Working with the PV Process, Partnership and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting

  • Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy

  • Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO responsibilities

  • Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment

  • Working with the PV Process, Partnership and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.

  • Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.

  • Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO responsibilities

  • Provide support and oversight to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection

With this in mind, we are looking for you that have a proven ability to work across cultures using your strong negotiation, conflict management and interpersonal skills to influence whilst maintaining independent and objective view.

Essential for the role

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

  • Experience in working cross-functionally

  • Leadership skills, including proven leadership of project teams experience

  • Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues

  • Thorough knowledge of the drug development process

Desirable for the role

  • Knowledge of new and developing regulatory and pharmacovigilance expectations

  • Knowledge of existing AstraZeneca external alliances and collaborative projects

  • Experience of working with third party suppliers

  • Experience in safety database functionalities

Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?

Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organisational goals!

So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. We welcome you with your application, no later than, October 11, 2022.

Date Posted

20-sep.-2022

Closing Date

10-okt.-2022

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

You’ve got this!