Global Patient Safety Lead — Pharmacovigilance & Compliance

BioSpace; Dublin (OH); Hybrid; USD 102.000 - 165.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Ausbildung

Pharmacy, nursing or equivalent qualification

Jobbeschreibung

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.