Temp Manager, Global Patient Safety Sciences

Regulatory Toolkit; Village of Tarrytown (NY); On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron seeks a Manager of Global Patient Safety to lead scientific safety strategies for molecules in clinical development and post-marketing. You will aggregate, review, and interpret safety data to support benefit-risk assessment and safety signal evaluation.

In this role, you will prepare DSUR/PSUR/RMP documents and interact with cross-functional teams, RSOC, and IDMCs. A strong background in pharmacovigilance and data visualization is required.

Qualifications

• Master of science degree, PhD, or PharmD.
• 5+ years of safety or risk management experience in pharma/biotech or health authority.
• Clinical experience in the therapeutic area of interest is a plus.

Responsibilities

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP) and respond to health authorities.
• Prepare and deliver presentations at SMT meetings and participate in clinical study teams.

Skills

Signal detection

Safety data analysis

Data visualization

Cross-functional collaboration

Education

MS/PhD/PharmD

Tools

Excel

Pivot tables

Job description

SUMMARY: The Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

SCOPE:

N/A

JOB 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 molecules 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
• Experience in data manipulation and visualization (Excel, PIVOT tables, etc) for safety analysis
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

JOB REQUIREMENTS:

Education

• Master of science degree, PhD, or PharmD.

Experience

• Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 5+ years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority
• Clinical experience and/or Industry experience in the TA of interest is a plus

Does this sound like you? We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.