Safety and Pharmacovigilance Specialist - USMD job in Bethesda at Technical Resources International
Technical Resources International
Bethesda, Maryland
This job has expired.
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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