Manager Pharmacovigilance Processes

Modis Life Science is now looking for a temporary consultant for an assignment at AstraZeneca in Gothenburg. For this role we are looking for a candidate with a science/pharmacy/nursing degree and preferably with knowledge and expereince of Pharmacovigilance and Patient safety. The assignment is initially 1 year. Send your application no later than May 6th. 

In your role you will be:

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.

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

Required background:

•A science/pharmacy/nursing degree
•Experience/knowledge in the Pharmacovigilance a/or Patient Safety area
•Experience in working cross-functionally
•Administrative skills including Sharepoint online expertise
•Project Management skills