Associate Director, Global Patient Safety - Ophthalmology

Regeneron Ireland; Dublin; Presencial; EUR 104.000 - 169.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Ireland seeks an Associate Director to join Global Patient Safety in Dublin, on-site three days per week with up to 25% travel. You will lead safety data aggregation, review and analysis to support safety interpretation and benefit-risk assessments for molecules in development and post-marketing.

The role demands a Master’s/PhD/PharmD with 10+ years in risk management within pharma/biotech, and strong knowledge of FDA/EU/ICH pharmacovigilance.

Formación

• Master's, PhD, or PharmD; terminal degree preferred.
• 10+ years of risk management experience in pharma/biotech or health authority.
• Strong knowledge of FDA, EU and ICH pharmacovigilance guidelines.
• Ability to work with safety databases and generate medical reviews.
• Proactive, self-disciplined, and able to meet deliverables.
• Excellent verbal and written safety communication.

Responsabilidades

• Complete signal detection in line with safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare/Review DSUR, PSUR, and RMP documents and regulator responses.
• Deliver presentations at SMT meetings.
• Participate in clinical study teams for assigned compounds.
• Contribute to risk management activities and SOP maintenance.
• Represent GPS on cross-functional/regulatory committees as needed.

Conocimientos

Risk management

Clinical safety

Communication skills

Self-motivation

Educación

Master's degree

PhD

PharmD

Herramientas

Safety system databases

DSUR/PSUR/RMP writing

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 an Associate Director to join our Global Patient Safety team. The Associate Director 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 assessments. 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: Dublin, IRE. 3 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 Resource for medical review of assigned compounds
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

This role requires:

• Minimum a Master's, PhD, or PharmD (Terminal Degree preferred)
• 10+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
• Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 8-10+ years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marking environments
• Ability to work with a safety system database for purposes of medical case review and simple querie
• 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
• Provide a background that includes: Master's, PhD, or PharmD Clinical experience and/or industry experience in the TA of interest is a plus

Salary

Salary Range (annually) €103,600.00 - €168,500.00

Benefits

• 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

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.

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.

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.

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.