Regeneron Pharmaceuticals
Senior Manager, Global Patient Safety - Immunology & Inflammation
Regeneron Pharmaceuticals, Warren, Michigan, United States, 48091
Overview
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. Responsibilities
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
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 you 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
Minimum qualifications
Master\'s, PhD, or PharmD required
Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
EEO and accommodations 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. For roles in the U.S., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, ranges are shown under 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 identity, right to work, and educational qualifications verification. Salary Range (annually) $126,700.00 - $206,900.00
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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. Responsibilities
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
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 you 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
Minimum qualifications
Master\'s, PhD, or PharmD required
Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
EEO and accommodations 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. For roles in the U.S., salary ranges are shown in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, ranges are shown under 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 identity, right to work, and educational qualifications verification. Salary Range (annually) $126,700.00 - $206,900.00
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