Temp Mgr Global Patient Safety Sciences

Regeneron Pharmaceuticals; Tarrytown (GA); On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager of Global Patient Safety to lead scientific safety strategies for molecules in development and post-marketing stages. Responsibilities include signal detection, evaluation, and preparation of DSUR/PSUR/RMP, plus presenting at SMT meetings and collaborating with cross-functional teams.

Candidates should have 5+ years in pharmaceutical safety or related clinical experience, with MS/PhD/PharmD and strong data analysis skills.

Qualifications

• Experience in signal detection activities.
• Experience in safety data aggregation, review and analysis.
• Strong data manipulation and visualization skills (Excel, Pivot tables).
• Prior work in pharma safety or risk management is required.

Responsibilities

• Complete signal detection activities in line with the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation and review of DSUR, PSUR, RMP, and safety responses.
• Deliver presentations at SMT meetings and participate in study team meetings.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC) as needed.
• Actively participate in process improvement initiatives and SOP development.

Skills

Signal detection

Safety analysis

Data visualization

Pivot tables

Education

MS/PhD/PharmD

Tools

Excel

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

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. 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.