Job Description

Job Description
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.
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.

Job Tags

Similar Jobs

Kraft Heinz Company

Corporate Chef Job at Kraft Heinz Company

...Functions: Marketing Date Published: January 5, 2026 Ref#: R-98563 ABOUT THE ROLE Job Description As a Corporate Chef , you will play a pivotal role in shaping and executing the culinary strategy for both the market and key customers for Kraft...

California Housing Partnership

Managing Director, Research (San Francisco/Hybrid) Job at California Housing Partnership

...mental health and personal support ABOUT THE CALIFORNIA HOUSING PARTNERSHIP The Partnership is a dynamic nonprofit think and do tank providing critical technical assistance, training, applied research and policy leadership to increase the production and...

Jeff D'Ambrosio Auto Group

Title Clerk Job at Jeff D'Ambrosio Auto Group

...agency? Jeff D'Ambrosio CDJR is currently looking for an experienced Title Clerk to join our motivated team. The ideal candidate will have at least one year of automotive dealership or title and tag company experience. We are looking for enthusiastic individuals who enjoy...

GMI Nation California LLC

Janitorial Position Job at GMI Nation California LLC

Janitorial position for California

Wing Assistant

Social Media Assistant (US) Job at Wing Assistant

...you are located in the US Social Media Assistant (Remote) Wing is... ...utilized by competitors, and marketing insights Develop or... ...written and verbal (at least B2 level) Solid organizational and time... ...is a remote job Salary: Entry Level (1-3 years of...

S & P Specialist Job at Technical Resources International, Inc., Bethesda, MD

M0VvOHV1eVRXSXlSMzVvNHlEQ0pwMm0wQlE9PQ==