Manager, Pharmacovigilance Processes, AstraZeneca Gothenburg

Job description
Working with the PV Processes leads and Process Principals, supporting tasks related to management of AstraZeneca projects, processes including implementation, communication, quality, compliance, tracking, performance and inspection readiness. Accountable to develop 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. This is a consulting assignment at AstraZeneca in Gothenburg.

Responsibilities
Collaborate with PV Process Leads and Principals with support the enhancement of existing processes
Working with the Process leads and Principals, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
Support PS Process owners with guidance, advice and support on PD process.
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, Lollipop, 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
Using understanding of PV and Regulatory processes and regulations to provide support to regulatory process team
Promote a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
Support and improve reporting tools and analysis processes and process metric /KPI data. Performing the monitoring, analysis and trending of data in own area of work.
Identify issues and risks in own area of work and propose options to mitigate them.
Ensure that appropriate, up-to-date records are maintained for compliance
support activities for GVP, GCP, GRP and GMP audits/inspections
Support Delivery of improvement project assignments supporting the business,
Provide process training to relevant functional groups or support preparation of training material.
Seek personal and professional development opportunities, and share knowledge gained in open forums
Contribute to communication and change management activities associated with process initiatives.
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


Qualifications
A science/pharmacy/nursing degree,
Experience in working cross-functionally
Administrative skills including Sharepoint online expertise
Project Management skills
Good attention to detail
Excellent written and verbal communication skills
Proven ability to work across cultures

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-05-05, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Birgitta Nyström +46733434153

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!