Description
- 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.
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