Associate Director, Global Patient Safety

Regeneron

Associate Director leading pharmacovigilance case operations for Regeneron's Global Patient Safety team. Overseeing vendor operations and ensuring compliance with regulatory standards.

Posted 7/15/2026full-timeTarrytown • Massachusetts, New York • 🇺🇸 United StatesSenior💰 $157,200 - $256,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Pharmacovigilance and Drug Safety, with a strong focus on ICSR quality standards, regulatory compliance, and team leadership. Proven ability to manage complex projects and mentor staff while ensuring timely case processing and vendor oversight.

Highest-signal resume keywords

Pharmacovigilance ExperienceICSR Quality StandardsFDA Guidelines KnowledgeTeam ManagementRoot Cause Analysis

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Case ProcessingQuality Review FrameworksCAPA ManagementData IngestionWorkflow Automation

Soft Skills

Strong CommunicationPartner ManagementIssue Resolution

Tools & Technologies

AI-Enabled Tools

Industry Keywords

Drug SafetyRegulatory ComplianceClinical TrialsPost-Marketing SurveillanceSOPs

About the role

Key responsibilities & impact

Own accurate, timely case processing across global development and marketed products, per applicable regulations and Regeneron SOPs.
Lead vendor oversight for end-to-end ICSR receipt, processing, distribution, and submission.
Own ICSR quality standards covering narrative, case validity, and source document reconciliation.
Establish tiered quality review frameworks aligned to case complexity, risk, and product lifecycle stage.
Monitor submission timelines and vendor SLAs, maintain inspection readiness, and respond to audit findings.
Lead root cause analysis and own CAPAs through closure and effectiveness checks.
Evaluate AI-enabled tools for data ingestion, workflow automation, and metrics.
Mentor staff and communicate clearly with senior management and partners.

Requirements

What you’ll need

Pharmacy, nursing, or equivalent degree required; advanced degree preferred.
Typically 10 years of Pharmacovigilance, Drug Safety, or PV Quality experience in pharma or biotech.
Well-informed on FDA, EU, and ICH guidelines governing pharmacovigilance for clinical trial and post-marketing environments.
Experience managing teams on complex, cross-functional projects.
Proven ability to deliver organisational projects through individual contributors or other managers.
Strong communication and partner management skills, with ability to resolve and escalate complex issues.

Benefits

Comp & perks

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