Local Case Intake Advisor, GBS Patient Safety - Romanian speaker

Introduction to role

Are you ready to make a difference in patient safety? As a Local Case Intake Advisor, you'll be at the forefront of managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level.

This pivotal role supports specific local Marketing Companies, ensuring compliance with AstraZeneca and national regulatory requirements. You'll serve as the primary liaison between these Marketing Companies and GBS-PS, working under the guidance of Case Intake Team Managers.

Expect to deliver routine activities independently, resolve moderate scope and complexity problems, and conduct interactions consistent with company values and compliance standards. Dive into a dynamic environment where your expertise will contribute to life-changing medicines!

Accountabilities

• Support Individual Case Safety Reports (ICSRs) processing and handling, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products.
• Assist with Health Authority interactions for ICSR-related queries.
• Contribute to effective operational implementation of the Quality Management System appropriate to the GvP discipline.
• Provide Patient Safety expertise and guidance within the local Marketing company related to issue management for key products.
• Participate in ad-hoc local Marketing Company projects.
  
  
  

Essential Skills/Experience

• Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs).
• Review, assess, and process safety data from various sources, distributing reports following applicable regulations and SOPs.
• Identify Product Quality Complaint (PQC) and Product Security complaints.
• Promptly support responses to regulatory authority queries related to Patient Safety.
• Implement Corrective and Preventative Actions in the event of local non-compliance.
• Conduct reconciliations ensuring accuracy of pharmacovigilance data transferred and received.
• Screen regulatory authority database periodically for adverse events.
• Perform literature search and related activities for MC product portfolio if required.
• Undertake manual follow-up disseminating clear information based on approved call scripts.
• Maintain filing and archiving practices of patient safety documents.
• Actively contribute to maintaining Good Pharmacovigilance Practice.
• Support external service providers to meet company and local regulatory PV requirements.
• Assist the local PS team in audits or regulatory authority inspections.
• Complete all required patient safety trainings and obtain access to relevant systems.
• Maintain current knowledge of relevant country regulatory authority regulations.
• Native or fluent proficiency in Romanian, with strong command of English
  
  
  

Desirable Skills/Experience

• Influencing and Conflict Resolution skills.
• Medical knowledge in company Therapeutic Areas.
• Project management experience.
• Successful participation in above-market projects.
• Audit & Inspection experience.
  
  
  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers an environment where meaningful work makes a bigger impact. As part of a global team dedicated to excellence and breakthroughs, you'll have the opportunity to genuinely impact patients' lives. Join us during an exciting time of growth through innovation, where you can shape our journey by reimagining how we work. Here, every person plays a part in our story—speak up, take initiative, and make it yours. With an unstoppable drive to learn, we are problem-solvers by nature, taking every opportunity to dig into complex challenges. Be part of a relationship-driven community where collaboration is key, and together we celebrate successes.

Ready to take action?

Apply now and become a trusted partner in our fast-growing organization!