Cpl Life Sciences

Global Patient Safety Manager

17 Feb 2021
18 Mar 2021
Joshua Aderinto
Clinical Research
Full Time
Contract Type
Experience Level

Cpl Life Sciences are actively recruiting for a Manager Global Patient Safety to join an exciting Biopharma company on an initial 12 month contract, however the role will have the opportunity to go permanent.

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

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