Safety and Pharmacovigilance Specialist - USMD job in Bethesda at Technical Resources International
Technical Resources International
Job Info
Responsibilities
Performs various tasks in support of clinical research including adverse event analysis and processing; serious adverse event reconciliation; preparation of IND safety reports for submission to the FDA; safety document or data analysis; clinical trial site support; reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development; assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary; may review experimental protocols and informed consent documents; and prepares, reviews, and edits presentations regarding safety issues.
Recommended Skills
- Ich Guidelines
- Clinical Research
- Good Clinical Practices (Gcp)
- Med Dra
- Oncology
- Presentations
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