Local Case Intake Advisor
AstraZeneca · Şişli
Job description
About the role
The Local Case Intake Advisor acts as the primary gateway for Individual Case Safety Reports, ensuring that every adverse event case is captured, assessed and reported accurately. This role supports patient safety and regulatory compliance by linking case intake activities to broader market continuity and trust.
Key responsibilities
- Coordinate receipt and handling of adverse event cases from clinical, post‑marketing and literature sources, meeting regulatory deadlines.
- Support health‑authority queries with clear, accurate information to demonstrate compliance.
- Contribute to quality management system activities, including procedural documentation, training, incident reporting and audit preparation.
- Mentor local marketing, sales, regulatory and medical teams on patient‑safety practices and risk‑management actions.
- Implement corrective and preventive actions for identified non‑compliance, such as late log processing.
- Perform data reconciliations and regularly screen regulatory databases for adverse events.
- Conduct literature searches for the local product portfolio to identify potential cases.
- Identify and triage product‑integrity and safety‑related complaints for downstream reporting.
- Oversee external service providers and license partners to ensure they meet local PV obligations.
- Prepare and support local teams for audits and regulatory inspections.
- Complete required training and maintain up‑to‑date knowledge of pharmacovigilance standards.
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Published 1 month ago
Expires 2 weeks from now
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AstraZeneca
Şişli