testing lead (with pharmacovigilance system focus) in gothenburg

Job description
Randstad technologies are now looking for a test lead for a consultant assignment at Astra Zeneca. Here you will be working in a team with covid-19 focus, an opportunity to be a part of  the vaccine development.


Randstad Technologies is specialized in competences within IT. 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 Technologies, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
The role holder focuses on delivering solutions and systems to address Business as Usual (BaU) in order to meet regulatory compliance.  Develops standardized operating procedures and best practice in order to ensure effective and efficient delivery of safety information across the organization. Demonstrates knowledge of safety / pharmacovigilance system requirements in order to meet business needs against the prioritized product portfolio.  Provides comprehensive technology evaluation and and ongoing stakeholder and vendor relationship management.  Works under the guidance of the PS Systems Lead to develop User Requirements Specifications (URS) and Benefit Realization Plans (BRPs) aligned with existing and new safety tools and applications.  Monitors industry trends across pharmacovigilance / safety information and works with the PS Systems Lead to best position AstraZeneca for current / future exploitation of data in the most cost-effective manner.

Working hours
Full time, assignment ends 2020-12-31.

Qualifications
•Highly proficient in executing UAT / OQ / Regression test scripts to ensure Health Authority gateways for acceptance of electronic submissions are fully functional.


•Strong knowledge of Health Authority system and validation requirements.


•Demonstrated ability to work alongside technical stakeholders to understand format requirements of Health Authority electronic gateways to ensure successful transmission of adverse event data.

•Bachelor’s degree in a scientific discipline, with relevant experience in supporting safety-related activities in the context of clinical biopharmaceutical development.
 
· Proven competence, with minimum of 3 years Patient Safety or closely-related pharmaceutical industry experience, preferably with extensive involvement in the successful design, delivery or deployment of information/systems solutions in support of safety or PV-related work.
· Broad knowledge of the safety information and analytics tools required to support drug development and marketed brands, including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, epidemiology practices, and changing safety project team activities.
· Experience in safety signal management, data visualization and reporting tools, and/or the exploitation of data used to define the safety profile.
· Knowledge of the procedures, processes and standards governing clinical trial data (documents and data) with health authorities worldwide, and experience of implementing these within the business.
· Able to identify opportunities to lead change through innovation – seeking continuous improvement based on strong awareness of external competitive practice.
 
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Experience
Minimum of 3 years Patient Safety or closely-related pharmaceutical industry experience.

Application
2020-08-31, 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: carolina.klockaregullesjo@randstad.se 

About the company
Randstad Technologies specializes in the field of IT and 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 IT. Our mission is to help you reach your true potential with your career in focus!