Local Case Intake Advisor, GBS Patient Safety - Czech speaker
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Local Case Intake Advisor, GBS Patient Safety - Czech speaker, Lisbon
Client:
Location:
Lisbon, Portugal
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
96e4c1527a9c
Job Views:
5
Posted:
15. 07. 2025
Expiry Date:
29. 08. 2025
Job Description:
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 ICSR 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 Gv
P discipline. - Provide Patient Safety guidance within the local Marketing company related to issue management for key products.
- Participate in
- hoc local Marketing Company projects. - Support 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.
- Support responses to regulatory authority queries related to Patient Safety.
- Implement Corrective and Preventative Actions in case of local
- compliance. - Conduct reconciliations ensuring accuracy of pharmacovigilance data transferred and received.
- Screen regulatory authority database periodically for adverse events.
- Perform literature searches for the MC product portfolio if required.
- Follow up manually with clear information based on approved call scripts.
- Maintain filing and archiving of patient safety documents.
- Contribute to maintaining Good Pharmacovigilance Practice.
- Support external service providers to meet PV requirements.
- Assist in audits or regulatory inspections.
- Complete all required patient safety trainings and systems access.
- Stay updated on relevant country regulations.
- Native or fluent Czech, strong English skills.
- Influencing and Conflict Resolution skills.
- Medical knowledge in company Therapeutic Areas.
- Participation in
- market projects.
We foster bold thinking through
- person teamwork, connecting, working at pace, and challenging perceptions. We expect a minimum of three days in the office weekly, balancing flexibility and collaboration. Join Astra
Zeneca’s environment where meaningful work impacts lives, and every team member contributes to our journey. Speak up, take initiative, and solve complex challenges with us. Be part of a community where collaboration and celebrating successes are key.
Ready to take action?
Apply now and become a trusted partner in our
- growing organization!
- Informações detalhadas sobre a oferta de emprego
Empresa: AstraZeneca Localização: Lisboa
Lisboa, Lisboa, PortugalPublicado: 16. 7. 2025
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