Medical Safety Reviewer
posted by: spj_bot
At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.
The Medical Reviewer provides medical and operational oversight of global pharmacovigilance review activities, ensuring high-quality assessment of ICSRs, compliance with regulatory requirements, and submission readiness for critical cases. The role also supports the continuous improvement and consistency of medical review processes, maintaining alignment with internal quality standards and global regulations.
Main Responsibilities:
- Perform medical review of ICSRs ensuring completeness and submission readiness.
- Manage complex/high-priority cases with appropriate clinical assessment.
- Ensure data quality and consistency in the safety database.
- Conduct targeted QC activities and drive corrective/improvement actions.
- Lead follow-up activities with internal teams, HCPs, and vendors.
- Oversee coding standards (MedDRA, WHO Drug) and ensure global consistency.
- Contribute to PV standards, training, and continuous improvement.
- Support benefit-risk evaluation and safety strategy activities.
- Act as SME for audits and inspections.
- Manage processes, vendors, and KPIs, driving operational performance.
Requirements