Scientific Expert and Pharmacovigilance Lead

hace 2 semanas

Murcia, Murcia, España Argenx A tiempo completo

Job Summary

As a Scientific Expert and Pharmacovigilance Lead, you will serve as a key resource for external and internal partners within the region, providing scientific expertise and pharmacovigilance support. You will assess current processes to ensure adherence to local and regional safety regulatory requirements, and develop new processes as needed to ensure consistency with global standards.

Key Responsibilities

• Act as a point of contact for pharmacovigilance in the assigned countries/region
• Establish and maintain the applicable pharmacovigilance system specific to the countries/region
• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the countries/region
• Provide support to responses to local pharmacovigilance related regulatory requests
• Communicate global procedures and practices and monitor implementation
• Lead the preparation of Pharmacovigilance Agreements (PVA) in collaboration with other departments
• Engage in due diligence activities as needed in the region when potential business partnerships or collaborations may take place
• Increase the visibility of the GPS team/function throughout Argentum with focus on region
• Participate in health authority interactions throughout the product life-cycle as needed
• Closely collaborate with other functions including regulatory, medical, communications, quality, legal, as well as other teams as needed
• Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with local and global requirements
• Develop relationships with cross functional teams and with business partners as it relates to adverse event reporting and other pharmacovigilance activities
• Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements
• Lead and actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the global Quality team
• Contribute to GPS issue management, recommend and implement action plans for mitigation
• Identify opportunities to align PV standards globally
• Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development
• Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance in the region
• Transparently communicate and/or escalate issues to GPS leadership as appropriate
• Drive Continuous Improvement initiatives as needed
• May perform other tasks as assigned by line manager or Head of GPS

Requirements

• Excellent presentation skills with the ability to communicate complex issues clearly
• Relevant computer skills, including proficiency with Microsoft Office Suite including PowerPoint / Visio
• Excellent planning and organizational skills with ability to manage competing priorities

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