Regeneron
Senior Manager, Global Patient Safety - Immunology & Inflammation
Regeneron, Trenton, New Jersey, United States
Senior Manager, Global Patient Safety - Immunology & Inflammation
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Senior Manager, Global Patient Safety - Immunology & Inflammation
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Regeneron . 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. Responsibilities include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit‑risk assessment. Typical Day Might Include
Complete signal detection activities in line with approved safety surveillance plan. Perform signal evaluation for any identified signals and author safety evaluation reports. Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses 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. 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., development and maintenance of relevant SOPs, WIs and supporting documents. Qualifications
Minimum a Master’s, PhD, or PharmD. 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority. 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 medical case review and simple queries. Proactive and self‑disciplined; able to meet deliverables and effectively use time and prioritize. Strong verbal and written communication skills for safety findings. 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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Join to apply for the
Senior Manager, Global Patient Safety - Immunology & Inflammation
role at
Regeneron . 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. Responsibilities include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit‑risk assessment. Typical Day Might Include
Complete signal detection activities in line with approved safety surveillance plan. Perform signal evaluation for any identified signals and author safety evaluation reports. Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses 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. 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., development and maintenance of relevant SOPs, WIs and supporting documents. Qualifications
Minimum a Master’s, PhD, or PharmD. 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority. 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 medical case review and simple queries. Proactive and self‑disciplined; able to meet deliverables and effectively use time and prioritize. Strong verbal and written communication skills for safety findings. 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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