Senior Vigilance Specialist

We are looking for a resourceful and proactive Senior Vigilance Specialist to strengthen our Post Market Surveillance team. As a Senior Vigilance Specialist, you play a critical role in safeguarding user safety and ensuring compliance with global regulations.

Requirements

• Supervise high-risk cases and adverse events, while mentoring Vigilance Specialists across all Business Areas.
• Maintain an overview of PSUR/PRER/PMSR and ensure timely compliance.
• Provide input to Quality Management Reviews with accurate vigilance data and statistics.
• Develop, maintain, and review Post Market Surveillance (PMS) Plans aligned with product risk profiles and regulations.
• Manage Field Safety Corrective Actions (FSCA) / Recalls per internal procedures and regulatory requirements.
• Contribute to complex projects, delivering in line with objectives and corporate strategy.
• Analyze internal and external data for Vigilance Intelligence System (VIS) to identify trends, risks, and country-specific reporting criteria.
• Support internal and external audits and inspections with documentation, case insights, and vigilance expertise.
• Act as primary liaison for vigilance matters, ensuring timely communication with Notified Bodies for compliance and safety.
• Monitor evolving regulatory requirements and translate them into actionable internal processes aligned with global vigilance standards.