PV/ Drug Safety Specialist
Duration: 1 year contract with extensions.
Location: Philadelphia, PA
The Drug Safety Specialist is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations and Company Pharmaceuticals standard operating procedures and guidelines.
The Drug Safety Specialist will perform accurate computer data entry of identified adverse event information and ensure the uniform and timely processing and reporting of adverse events to regulatory authorities.
The Drug Safety Specialist will be responsible for performing quality review of individual case safety reports and for providing feedback to team members, working closely with the Case Processing team and Medical Reviewers to ensure complete and accurate information has been entered into the safety database.
- Processes adverse event information received by the Drug Safety and Pharmacovigilance department and assists in the preparation of internal and external reports
- Performs accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities
- Reviews adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance with department processes
- Performs quality control activities to ensure complete and accurate case information has been entered into the drug safety database
- Requires a health care professional background, either nurse or PharmD and a minimum of 3 years drug safety experience, or
- BS/BA degree in a health related or biological science related field and 5 years of experience, or
- Equivalent combination of education and experience
- Experience in safety case processing as well as quality review of individual case safety reports, both in-process and via sampling, is preferred
- Experience using ARGUS or other safety database applications
Sthree US is acting as an Employment Business in relation to this vacancy.