Local Case Intake Advisor, GBS Patient Safety - Bulgarian speaker Lisboa

Local Case Intake Advisor, GBS Patient Safety - Bulgarian speaker

Join to apply for the Local Case Intake Advisor, GBS Patient Safety - Bulgarian speaker role at Astra
Zeneca

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 Astra
Zeneca 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
- changing medicines!

Accountabilities

• Support Individual Case Safety Reports (ICSRs) processing and handling, including adverse event reporting from clinical and
  - marketed sources for Astra
  Zeneca 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
  - 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
  - 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
  - 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 Bulgarian, 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
  - market projects.
• Audit & Inspection experience.

Astra
Zeneca offers an environment where meaningful work makes a bigger impact. As part of a global team dedicated to excellence and breakthroughs,
- 'll have the opportunity to genuinely impact
- ' 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
- solvers by nature, taking every opportunity to dig into complex challenges. Be part of a
- driven community where collaboration is key, and together we celebrate successes.

Date Posted: 14-ago-2025

Closing Date: 11-set-2025

AZ embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with a wide range of perspectives as possible. We comply with all applicable laws and regulations on
- discrimination in employment and work authorization.