Description
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.
Skills
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
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)