Associate, Medical Safety Operations
|Job Title:||Associate, Medical Safety Operations|
|Contact Name:||Reece Mitellas|
|Job Published:||November 13, 2017 17:32|
Essential Duties/ Responsibilities
- Performs internal activities and oversight of outsourced activities for individual case safety report (ICSR) processing and reporting from all sources in compliance and quality according to company procedures and regulatory requirements.
- Ensures that expedited and periodic safety reports to regulatory agencies and license partners are submitted and compliance is tracked.
- Liaises with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs.
- Safety data extraction and production from MS systems for internal partners and regulatory submissions
- Performs receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases.
- Collaborates with QA on product complaints associated with ICSRs.
- Supports regulatory agency interactions (both written and verbal), inspections, and audits.
If your experience and availablity matches the description, you are currently based in the United States, eledgiable to work in the united states and are set up to work Corp2Corp please apply.
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