Job Description

This is a hybrid position with 2 days in Bethesda/Rockville Maryland office, and 3 days working remotely.

• Ensures compliance with 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.

Job Requirements

• 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.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit .

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

Job Tags

Full time, Work at office, Remote work, Worldwide

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