Manager, Global Patient Safety Scientist

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team. The role involves leading signal detection and evaluation activities, preparing DSUR/PSUR/RMP documents, and presenting findings to the SMT.

On-site collaboration across Sleepy Hollow, NY; Warren, NJ; and Cambridge, MA is expected with some travel. Ideal candidates hold a Master, PharmD, or PhD with 5+ years in pharmacovigilance or related clinical roles, excellent data analysis skills, and

Qualifications

• Minimum 5+ years of risk management or relevant clinical experience in pharma/biotech industry or health authority.
• Ability to apply FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities.
• Experience with safety signals and DSUR/PSUR preparation preferred.

Responsibilities

• Complete signal detection activities in line with safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review safety documents including DSUR, PSUR, and RMP; respond to health authority queries.
• Prepare and deliver presentations at Signal Management Team meetings; participate in cross-functional teams.
• Represent GPS on cross-functional teams such as RSOC or IDMC as needed.
• Utilize Excel and visualization tools for safety data analysis.
• Contribute to SOPs, WIs, and other process improvement initiatives.

Skills

Data analysis

Communication skills

Time management

Self-motivation

Education

Master degree

PharmD

PhD

Tools

Safety database

Data visualization tools

Job description

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.

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

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.

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.