Our client is a large pharmaceutical company who is looking for auditors to conduct an internal gap assessment on their pharmacovigilance department.
Day to Day Responsibilities:
The client is looking for someone to come on sit and provide subject matter expertise for their drug safety department. The client is looking for someone who can come on site and look at their current practices for reference safety information, investigations sponsored studies and post market requirements and determine if they are compliant with GVP guidelines. These guidelines are specific to the European market in particular. The consultant will conduct the gap assessment and provide advice on how to resolve any issues that have popped up.
- Reference safety report
- investigator sponsored studies
- post market requirements