Hybrid: Associate Director, Global Patient Safety

Regeneron Ireland; Dublin; Hybrid; EUR 102,000 - 165,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Ireland is seeking an Associate Director to lead the pharmacovigilance case operations team in a hybrid setting. The role involves overseeing ICSR receipt, processing, and submission across global programmes, while managing vendors and ensuring quality and regulatory compliance.

You will mentor staff, optimize AI-enabled data ingestion, and drive audits and inspections. The position offers impact across Regeneron’s global portfolios and partnerships.

Qualifications

• Pharmacovigilance or drug safety experience, ideally in quality.
• Supervisory experience on complex projects with cross-functional teams.

Responsibilities

• Oversee timely ICSR receipt, processing, distribution and submission across global development and commercial programmes.
• Maintain vendor resourcing, training, volume readiness and structured feedback.
• Own ICSR quality standards, narrative quality, validity, assessment completeness and source reconciliation.
• Tailor tiered reviews and sampling to complexity, risk and lifecycle stage.
• Optimise AI-enabled data ingestion, quality workflows and metric generation.
• Support audits and health authority inspections, maintaining inspection readiness.
• Lead root cause analysis and targeted remediation for recurring errors.
• Own corrective and preventive actions through closure and timely commitments.
• Escalate delivery risks.
• Establish KPI frameworks covering volumes, cycle times, resource utilization and vendor benchmarks.
• Conduct vendor governance against SLAs.

Skills

Pharmacovigilance experience

Education

Pharmacy, nursing or equivalent

Advanced degree preferred

Job description

Regeneron Ireland is seeking an Associate Director to lead the pharmacovigilance case operations team in a hybrid setting. The role involves overseeing ICSR receipt, processing, and submission across global programmes, while managing vendors and ensuring quality and regulatory compliance.

You will mentor staff, optimize AI-enabled data ingestion, and drive audits and inspections. The position offers impact across Regeneron’s global portfolios and partnerships.