Senior Manager, Global Patient Safety Hematology

Warren, OH - USA

Monthly Salary: $ 150500 - 245500

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the assigned 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:

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 can/have the:

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

To be considered for this opportunity you must have the following:

Minimum a Masters PhD or PharmD
Offers 7 years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority

#GDPSJobs

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$150500.00 - $245500.00

Required Experience:

Senior Manager

In this role a typical day might include:

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 can/have the:

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

To be considered for this opportunity you must have the following: