Associate Director Global Patient Safety Sciences

BioSpace; Dublin (OH); Hybrid; USD 102,000 - 165,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead the pharmacovigilance case operations team in a hybrid role. You will oversee ICSR processing quality, audits, and escalation workflows across global development and commercial portfolios, while partnering with vendors and internal peers.

You will set quality standards, drive risk-based reviews, support inspections, and mentor staff to ensure timely, compliant safety submissions and operational readiness.

Qualifications

• Global pharmacovigilance experience with ICSR processing and lifecycle oversight.
• Experience supervising teams on complex projects and successful cross-functional collaboration.
• Knowledge of FDA, EU and ICH pharmacovigilance requirements.
• Ability to drive corrective actions and remediation in QA/QAQC contexts.
• Advanced degree preferred.

Responsibilities

• Oversee timely ICSR receipt, processing, distribution and submission across global development and commercial programmes.
• Own ICSR quality standards, narrative quality, validity and source reconciliation; tailor reviews by complexity and lifecycle stage.
• Optimise data ingestion, quality workflows and metric generation.
• Support audits and health authority inspections, coordinating findings and remediation actions.
• Own corrective and preventive actions, escalate delivery risks when needed.
• Establish KPI frameworks for volumes, cycle times, resource utilisation and vendor benchmarking.
• Maintain submission timelines and SOPs; mentor staff and communicate deliverables to management.

Education

Pharmacy, nursing or equivalent qualification

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‑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: 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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