Temp Senior Manager, GPS Safety Sciences

Pay Range: $77.76 - $100.12/hr

Remote Role (US Only)

12 Month Contract

The Temp- GPS Safety Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases for our Internal Medicine Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

In this role, 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 Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds

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 (RSOC), Independent Data Monitoring Committees (IDMC) 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:

Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments

Ability to work with a safety system database for purposes of medical case review and simple queries

Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize

Ability to effectively communicate (verbal and written) safety findings

Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 5 years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority

Clinical experience and/or industry experience in the TA of interest is a plus

To be considered for this opportunity, you must have a Master's, PhD, or PharmD with 5+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation