BioSpace
Senior Manager, Global Patient Safety - Immunology & Inflammation
BioSpace, Trenton, New Jersey, United States
Senior Manager, Global Patient Safety - Immunology & Inflammation
Join to apply for the Senior Manager, Global Patient Safety - Immunology & Inflammation role at BioSpace.
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
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
Minimum a Master's, PhD, or PharmD
Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
Salary Range (annually) $148,300.00 - $241,900.00
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 Company's business.
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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
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
Minimum a Master's, PhD, or PharmD
Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
Salary Range (annually) $148,300.00 - $241,900.00
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 Company's business.
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