The Manager Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.
A typical day might include the following:
- Complete signal detection activities in line with approved safety surveillance plan
- Perform signal evaluation for any identified signals and author the safety evaluation reports
- Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
- Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings for assigned molecules
- Participate in other risk management activities as appropriate for assigned compounds
- We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron
- Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents
This role might be for you if:
We will draw on your ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
Be are able to utilize GPS safety system database for purposes of medical case review and simple querie
Be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
We expect you can effectively communicate (verbal and written) safety findings
We seek a Master's, PhD, or PharmD. You must also have 5+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
