Perform individual case safety reports (ICSR) processing which includes:
- Data intake and duplicate search
- Review, rank, verify, process and document case-related information: event terms, validity, seriousness, special scenarios, timelines, accuracy, and consistency. Process cases based on these assessments.
- Translate incoming reports from local language to English and English to local language, as needed.
- Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately. Write and edit case narrative.
- Determine and perform appropriate case follow-up, including generation of follow-up requests.
- Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.
- Perform regulatory submission to Health Authorities and the internal documentation of the process.
Monitor electronic mailboxes and Global Tracking Tool (e.g. JASPER) to ensure timely acceptance of Adverse Event (AE) Reports.
Organize and monitor electronic and physical Pharmacovigilance documentation, and perform data entry into databases, as needed.
Reviews weekly local language medical or scientific literature to identify possible case reports, and forwards in a timely manner to the AZ Patient Safety Data Entry Site (DES).
Updates local information relating to pharmacovigilance activities so it is reflected correctly in the Pharmacovigilance System Master File (PSMF).
Perform and record reconciliations from Market Research Programs, Patient Support Programs, and others.
Responsible for submission and tracking of Patient Safety documentation to regulatory authorities, such as ICSR reports, PBRERs, RMPs, PSLLs and others.
Support in activities related to safety documentation such as: Risk Minimization Plans, additional Risk Minimization Activities, DHPCs, Promotional Materials, etc.
Plan and deliver training to Pharmacovigilance and other areas.
Supports compliance with both AZ requirements and global/local regulatory requirements for patient safety and ensures corrective and preventative actions are taken in the event of local non-compliance.
Maintains in-depth knowledge of local authorities and regulations and ensures through the PSM that upcoming changes in legislation/guidance are notified to the regional lead for discussion and escalation to relevant stakeholders in Global Patient Safety as required.
Support other functions related to the position.
**Education, Qualifications, Skills and Experience**
University Degree in Pharmacy, Medicine, Biochemistry, Chemistry, or Biology.
- Related experience in the pharmaceutical/biopharmaceutical industry, specifically in the Pharmacovigilance area.
- Knowledge of GVP and relevant local regulation.
- Advanced English level (spoken and written).
Knowledge of GMP, GDP and GCP.
- Good analytical skills.