Associate Director Global Patient Safety

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

Job summary

Regeneron Pharmaceuticals is seeking an Associate Director to join the pharmacovigilance case operations team in a hybrid setting. You will oversee ICSR receipt, processing, and submission across global development and commercial programmes, while maintaining quality standards and coordinating with vendors and partners.

The role requires a pharmacy or nursing qualification (advanced degree preferred) and extensive pharmacovigilance experience, with leadership of cross-functional teams and strong

Qualifications

• Pharmacovigilance, drug safety or pharmacovigilance quality experience is required.
• Experience supervising teams on complex projects and cross-functional collaboration is required.
• Regulatory knowledge across FDA, EU and ICH pharmacovigilance requirements is required.

Responsibilities

• Oversee ICSR receipt, processing, distribution and submission across global development and commercial programmes.
• Own ICSR quality standards, narrative quality, validity and assessment completeness.
• Lead audits/inspections readiness and lead root cause analysis with remediation.
• Establish KPI frameworks for volumes, cycle times, resource utilisation and vendor performance.
• Mentor staff and manage workload, escalation and delivery risks.

Education

Pharmacy, nursing or equivalent qualification

Advanced degree preferred

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 Associate Director to join our pharmacovigilance case operations team, supporting our global portfolios in a hybrid setting. In this role, you will oversee case processing quality and operational readiness while collaborating with vendors and internal and external partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Multiple locations are being considered for this role (Hybrid).

Discover your role:

• Oversee timely individual case safety report (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 artificial intelligence-enabled data ingestion, quality workflows and metric generation.
• Support audits and health authority inspections, maintaining inspection readiness and coordinating findings responses. Lead documented, actionable root cause analysis and targeted remediation for recurring errors, deviations and compliance failures.
• Own corrective and preventive actions through closure, post-implementation effectiveness checks and timely commitments. Escalate delivery risks.
• Establish key performance indicator frameworks covering volumes, cycle times, resource utilisation, overtime and vendor benchmarks. Conduct vendor governance against contractual service-level agreements.
• Maintain regulatory, licence-partner and third-party submission timelines, standard operating procedures and working instructions. Mentor assigned staff and communicate deliverables, interests and issues promptly to management and partners.
• You balance workloads, compliance and quality through practical issue resolution and appropriate escalation.

This role requires:

• Pharmacy, nursing or equivalent qualification.
• Pharmaceutical/biotechnology pharmacovigilance, drug safety or pharmacovigilance quality experience, typically 10 years.
• Knowledge of Food and Drug Administration, European Union and International Council for Harmonisation pharmacovigilance requirements across clinical trials and post-market ing.
• Experience supervising teams on complex projects and successful cross-functional collaboration.
• Organisational project and goal management through individual contributors or managers, supporting colleagues as needed.
• Advanced degree preferred.

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.

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.

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)

€101,500.00 - €165,200.00