Manager, Pharmacovigilance Processes
Location: Cambridgeshire, Cheshire East, Gaithersburg, Maryland
Job Type: Full time
Do you have knowledge in regulatory requirements in pharmacovigilance and experience in working with process management Do you have a “can do” attitude and an innovative approach and want to contribute to ensure good process management and oversight Patient Safety within Astra Zeneca? Then this 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 PV Processes, Partnerships and Contracts group in Patient Safety CMO as a Manager PV Processes.
We are responsible for the management of assigned AstraZeneca processes, projects and partnerships including implementation, communication, compliance, performance and inspection readiness within Pharmacovigilance. We ensure good relationships across Patient Safety and Centre of Excellence 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 the PV Process Manager you will support tasks related to management of AstraZeneca projects, processes including implementation, communication, quality, compliance, tracking, performance and inspection readiness. You will work cross functional, developing relationships across Patient Safety and other relevant areas of AZ to execute the delivery of the assigned tasks in relation to processes strategy, priorities, alongside governance and management of the current procedural documents. A big part of the role is to support PS Process owners with guidance, advice and support on PD process and promote a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
You will also:
Collaborate with PV Process Manager, Associate Director and Director with support the enhancement of existing processes
Working with the Process Managers, Associate Directors, Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
Author and collaborate with SMEs to deliver assigned Toolkit documents and templates.
Maintain and continuously improve key customer facing service solutions for Process guidance and document access (R&D Process Portal, PSDM SPOL, Q&A ticket portal etc).
Coordinate specific tasks related to procedural document management to provide oversight to the Pharmacovigilance (and PS) process team
Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships
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.
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.