Medical Case Manager
1 day ago
We are seeking a skilled Clinical Safety Specialist to join our Pharmacovigilance team at Medpace in Stirling. In this role, you will work closely with cross-functional teams to collect, process, and track serious adverse event reports, generate safety narratives and queries, and perform Safety Database data entry, quality control review, and TMF uploads.
Responsibilities- Collaborate with Medical Monitors, Quality Assurance, and Clinical Trial Management to ensure timely completion of tasks and projects.
- Apply advanced knowledge of medical terminology and global safety reporting requirements to generate safety narratives and queries.
- Maintain compliance with GCP Guidelines through Safety Database data entry, quality control review, and TMF uploads.
Additional Responsibilities:
- Develop presentation material and present during face-to-face sponsor meetings, including kick-off meetings and investigator meetings.
- Coordinate final medical review of study report narratives and submission to medical writers.
- Develop drafts of adjudication material, such as charters and reporting materials.
- Minimum Bachelor's degree in a life science field.
- 2+ years of clinical trial pharmacovigilance experience.
- Working knowledge of Safety Databases, with Argus being desirable.
We estimate the salary for this role to be around $65,000-$80,000 per year, based on location and experience.
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