Position - Temp - Associate Director, Safety Scientist
Pay Range - $105/hr - $120/hr
Location - Remote
Duration - 6 Months

As a Temp- Associate Director of Global Patient Safety (GPS) you will play a key scientific role in safety strategies for our molecules in clinical development and post-marketing phases. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessments.

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 our 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
•    Participate in other risk management activities as appropriate for assigned compounds
•    May represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other external collaborators
•    Resource for medical review of assigned compounds
•    Participate in our process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

To be considered you must have a minimum Master’s Degree, Ph. D or PharmD in safety or relevant clinical experience in the pharmaceutical industry. This should include least 10+ years of risk management in pharmaceutical/ biotech industry or health authority. Ability to apply FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities. 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

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