Clinical Safety Associate

Job Duties/Responsibilities:

* Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
* Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
* Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
* Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
* Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
* Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
* Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
* Participates on Study Management Teams (as applicable)
* Assists in the development of drug safety presentation for investigator meeting presentations.
* Assists in clinical trial reconciliation process (as applicable).
* Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
* Ensures departmental workflow processes and timelines are followed.

Competencies Identified for Success:

* Works effectively as a team member and promotes collaboration
* Demonstrates initiative and accountability
* Strong organizational skills, detail oriented, ability to adapt to change
* Confident decision maker

Education, Experience, and Other Requirements:

* RN, BSN, PA, NP, MSN, MD, or PharmD required
* Minimum 2 years of clinical experience in a health care related field
* Computer proficiency and data entry experience preferred
* Excellent communication skills, both written and verbal
* Previous experience in Drug Safety (preferred)
To find out more about Real please visit www.realstaffing.com