Associate Director Global Patient Safety
$176.1k - $287.3kRegeneron Pharmaceuticals, Inc.
Regeneron seeks an Associate Director for Global Patient Safety to lead pharmacovigilance case operations across global development and commercial programs. The role involves overseeing individual case safety report processing, quality standards, vendor management, and regulatory compliance in a hybrid setting.
Responsibilities
- Oversee timely receipt, processing, distribution and submission of individual case safety reports across global programs
- Maintain and enforce ICSR quality standards, narrative quality, validity and assessment completeness
- Optimize artificial intelligence-enabled data ingestion, quality workflows and metric generation
- Lead root cause analysis and corrective/preventive actions for recurring errors, deviations and compliance failures
- Establish KPI frameworks and conduct vendor governance against service-level agreements
Requirements
- Pharmacy, nursing, or equivalent professional qualification
- 10+ years pharmacovigilance, drug safety, or pharmacovigilance quality experience in pharmaceutical or biotechnology
- Knowledge of FDA, EU, and ICH pharmacovigilance requirements for clinical trials and post-marketing
- Experience supervising teams on complex projects with strong cross-functional collaboration skills
- Demonstrated organizational and project management capabilities
- Advanced degree preferred
Compensation: $176,100–$287,300 base annually
Vacancy posted 5 days ago
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