Associate Director, Global Patient Safety - Ophthalmology

Regeneron Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension plan

Health benefits

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join its Global Patient Safety (GPS) team in Dublin, Ireland.

The role focuses on safety strategies for molecules in clinical development and post‑marketing, including data aggregation, safety interpretation and benefit‑risk assessments. Located in Dublin with 3 days on site per week and ~25% travel, the position offers a chance to influence safety programs across development stages while collaborating with RSOC, IDMC and

Qualifications

• Master's, PhD or PharmD (terminal degree)
• 10+ years of risk management experience in pharma/biotech or health authority
• Experience in safety or clinical safety in pharma/biotech industry
• Ability to apply FDA/EU/ICH pharmacovigilance guidelines

Responsibilities

• Complete signal detection activities per safety surveillance plan
• Perform signal evaluation and author safety evaluation reports
• Prepare/review DSUR, PSUR, and RMP documents and respond to health authorities
• Prepare and present at SMT meetings; collaborate with clinical study teams
• Represent GPS on cross-functional teams (RSOC, IDMC) as needed
• Provide medical review for assigned compounds
• Contribute to SOPs, WIs and related documents for process improvement

Skills

Signal detection

Pharmacovigilance

Risk management

Regulatory guidelines (FDA/EMA/ICH)

Safety reporting

Education

Master's, PhD or PharmD

Tools

Safety database

DSUR/PSUR/RMP

Job description

Position Overview

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)
• Offers 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‑marketing 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

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

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/ . For other locations, additional information will be provided during the recruitment process.

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, ethnicity 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.