Location: Warsaw or Cracow

Global Clinical Solutions ​department (GCS) drives the delivery of Business Process Excellence and Technology for the Clinical Operations organization, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.  

The GCS Specialist – Safety Distribution Specialist is expected to be able to take the following roles within the team:

• Country coordinator – is responsible for safety reports submission to Investigators and Ethics Committees by:
  o submitting safety reports according to regulatory timelines and requirements
  o serving as subject matter expert Safety Submission area for particular countries,
  o cooperation with local Patient Safety Managers for alignment on regulatory requirements understanding
• Project team member – actively participating in project tasks. Owning and keeping timelines of parts of the project
   

The team members will be cooperating with:

• Local Study Team Representatives to confirm distribution method and resolve delivery issues
• Patient Safety Managers to receive input to country regulatory requirements documentation
• External Service Providers Representatives to discuss countries requirements and resolve issues
• Cross-Functional Teams for project management initiatives
• Audit and Inspection team to provide clarification on the country distribution process and answer requests
   

Essential qualifications:

• University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines
• Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities
• Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time, cost and quality
• Computer proficiency
• Excellent knowledge of spoken and written English
• Strong business communication and presentation skills
• Ability to transfer knowledge efficiently (mentorship/trainings)

Desirable qualifications:

• Experience in Drug Development within a pharmaceutical or clinical background
• Experience in the development and management of Business Process to deliver business performance
• Comprehensive knowledge of ICH GCP
• Some experience of Quality Systems and Quality Management, including process definition and process improvement
• Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement would be an asset
• Some experience in Validation/User Acceptance Testing of computerized systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, Reports, Test scripts (including test scripts execution), Functional Risk Assessment etc. and knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure
• Knowledge of Safety Handling in Clinical Trials Process

What we offer

Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.

To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:

• gym access,
• after-work events,
• lunch & learns,
• bright and spacious environment,
• sustainable office working environment,
• networking events

Additionally, we`re happy to offer wide and various benefits package, including yearly bonus, multisport card, even up to 5 days of additional holidays, pension plan, private medical care, life insurance and a lot more...

We are looking forward to your application and are open to a variety of candidates with different levels of experience, depending on the level of your experience and competencies.

Apply today and find out more!

Date Posted

Closing Date

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.