Manager, Global Patient Safety Scientist

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Sur place; USD 115 000 - 187 000; Plein temps

Avantages offerts par ce poste

Annual bonus or incentive plans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental,)

Paid time off

Family support benefits

Résumé du poste

Regeneron Pharmaceuticals, Inc (USA) is seeking a Manager for Global Patient Safety Sciences in a 4-day on-site role based in Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA with ~25% travel. You will lead safety strategies for molecules in development and post-marketing, including data aggregation and safety interpretation.

You will drive signal detection/evaluation, prepare safety documents, and present at SMT meetings. Strong data analysis and cross-functional collaboration are essential.

Qualifications

• Minimum Master degree, PharmD, or PhD.
• Safety or relevant clinical experience in pharma/biotech required, typically 5+ years.
• Experience with pharmacovigilance and safety surveillance appreciated.

Responsabilités

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review DSUR, PSUR, and RMP documents.
• Deliver presentations at SMT meetings and participate in study teams.
• Engage in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams and committees.
• Utilize Excel and pivot tables for safety data analysis.
• Contribute to process improvements and SOP development.

Connaissances

Signal detection

Signal evaluation

Safety data analysis

Data visualization

Presentations

Cross-functional teamwork

Communication

Formation

Master's degree

PharmD

PhD

Outils

Excel

Pivot tables

Description du poste

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Global Patient Safety Sciences team. 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where: Work Location: Sleepy Hollow, NY, Warren, NJ or Cambridge, MA 4 days per week on site 25% Travel may be required

Discover your role

• 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
• 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

This role requires

• Minimum Master degree, PharmD, PhD
• Previous safety or relevant clinical experience in the pharmaceutical industy 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
• 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 querie
• Demonstrates advanced understanding of safety surveillance activities and principles; continues to operate under supervision by more senior members of the GPS safety sciences team
• 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.

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
• family support benefits

Salary Range (annually) $114,800.00 - $187,400.00

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, 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.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Regeneron is committed to building a workplace with an inclusive culture.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.