- Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
- Develops and ensures the uniform and timely processing of adverse event reports
- Provides medical evaluation of adverse event reports
- Performs various tasks in support of clinical research including the 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
- Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
- Performs literature searches
- 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 prepare, review, and edit presentations regarding safety issues.
- Knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential.
- Knowledge of safety databases and/or MedDRA coding preferred.
- Experience leading clinical and cross functional teams is a plus.
- Must have excellent oral, written, presentation and computer skills.
- 2+ years of academic, pharmaceutical or biotech industry or academic experience.
- This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
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Account Specialist-SRS I
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TMF Specialist
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Warehouse Specialist
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HVAC Specialist
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QA Specialist
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Fitness Specialist
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Contract Specialist
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Contract Specialist
1 week ago
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Accounting Specialist
1 week ago
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QA Specialist
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Communications Specialist
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S & P Specialist - Bethesda - Technical Resources International
Description
Job Title
S & P Specialist
Location
Bethesda, MD 20817 US (Primary)
Category
Drug Safety
Job Type
Full-Time
Salary Range
70, ,000.00/YEAR
Education
Master's Degree
Travel
None
Job Description
-
Account Specialist-SRS I
Only for registered members Bethesda
-
Dental Front Office Coordinator
Only for registered members Bethesda, MD
-
Dental Assistant
Only for registered members Bethesda, MD
-
Orthodontic Treatment Coordinator
Only for registered members Bethesda, MD
-
TMF Specialist
Only for registered members Bethesda, MD
-
TMF Specialist
Only for registered members Bethesda, MD
-
Authorization Specialist
Only for registered members Bethesda, MD
-
Fitness Specialist
Only for registered members Bethesda, MD
-
MTM Specialist
Only for registered members Bethesda
-
Revenue Specialist
Only for registered members Bethesda, MD
-
Math Specialist
Only for registered members River Rd Bethesda, Maryland, United States
-
Warehouse Specialist
Only for registered members Bethesda, MD
-
HVAC Specialist
Only for registered members Bethesda, MD
-
QA Specialist
Only for registered members Bethesda, MD
-
Fitness Specialist
Only for registered members Bethesda
-
Contract Specialist
Only for registered members Bethesda, Maryland, United States
-
Contract Specialist
Only for registered members Bethesda
-
Accounting Specialist
Only for registered members Bethesda
-
QA Specialist
Only for registered members Bethesda, MD
-
Registrar Specialist
Only for registered members Bethesda, MD
-
Communications Specialist
Only for registered members Bethesda, MD