Local Case Intake Advisor, GBS Patient Safety
On-siteLisboa, Província de Zambézia, Republic of Mozambique
Job Summary
Manage and process Individual Case Safety Reports (ICSRs) and adverse event reports from post-marketed sources while supporting Health Authority interactions and queries. Review, assess, and distribute safety data in line with regulatory requirements and SOPs, ensuring compliance with internal procedures and external standards. Contribute to Quality Management Systems, including audit readiness, and perform reconciliations to maintain data accuracy. Identify and manage product quality complaints and conduct literature searches or regulatory database screening where required. Collaborate with local Patient Safety teams and cross-functional stakeholders to resolve local case intake issues and support designated AstraZeneca Marketing Companies.
Required Qualifications
- Degree in Pharmacy, Medicine, or Life Sciences
- Knowledge of pharmacovigilance (PV) and health authority regulations
- Strong attention to detail and analytical mindset
- Excellent written and verbal communication skills
- Ability to work collaboratively across functions and geographies
- Problem-solving skills with the ability to manage moderate complexity
- Fluency in English
- Fluency in German
Desired Qualifications
- Experience in audits and inspections
- Knowledge of AstraZeneca therapeutic areas
- Project management experience
- Familiarity with safety systems (e.g. Argus)
- Additional language skills
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