Associate Director Global Patient Safety

Regeneron Ireland; Dublin; Hybrid; EUR 102.000 - 165.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Equity awards

Pension benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

Pharmacovigilance experience

Ausbildung

Pharmacy, nursing or equivalent

Advanced degree preferred

Jobbeschreibung

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-marketing.
• 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.

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:

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, 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) €101,500.00 - €165,200.00

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.