Manager, Global Patient Safety Scientist

Regulatory Toolkit; New Jersey; Presencial; USD 115.000 - 187.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Manager to join the Global Patient Safety Sciences team to lead safety strategies for molecules in clinical development and post-marketing phases. The role involves safety data aggregation, review, and analysis to support safety interpretation and benefit-risk assessment.

Location options include Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA with 4 days on site per week and up to 25% travel.

Formación

• Significant safety or clinical experience in pharma/biotech, 5+ years.
• Experience with pharmacovigilance and regulatory guidelines (FDA, EU, ICH).
• Ability to manipulate safety data and produce DSUR/PSUR/RMP documents.

Responsabilidades

• Perform signal detection and evaluation for safety data.
• Prepare DSUR, PSUR, and RMP documents.
• Prepare and deliver safety presentations for SMT and clinical study teams.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams as needed.

Conocimientos

Data visualization

Communication skills

Safety data interpretation

Cross-functional collaboration

Educación

Master degree

PharmD

PhD

Herramientas

Safety database

Descripción del empleo

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

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. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

Salary Range (annually)

$114,800.00 - $187,400.00