EU Global Regional Lead

PURPOSE OF THE FUNCTION

• Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region
• Assess current processes to ensure adherence to local/regional safety regulatory requirements and - where needed - enhance and/or develop new processes while assuring consistency with global standards.

ROLES AND RESPONSIBILITIES

• Act as 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 argenx 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.

SKILLS AND COMPETENCIES

• 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
• Excellent oral and written communication skills - fluency in written and spoken English required
• Strong ability to motivate, influence, and collaborate with multidisciplinary teams
• Ability to work independently and in a global environment
• Solid understanding of safety business processes and systems for the collection and evaluation of adverse events
• Problem solving, conflict resolution and critical thinking skills
• Demonstrated ability to author or contribute to complex documents
• Line Management experience is not required, but experience in the oversight of functional teams would be a plus

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Master’s degree (or country equivalent) in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
• At least 7 or more years of experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (experience with adverse event monitoring and reporting with digital/social media, market research, and relevant commercial and marketing related projects and programs is a plus)
• Advanced knowledge of pharmacovigilance regulatory requirements globally including and GVP guidance documents
• Robust knowledge of the drug development process, GXP quality and compliance requirements,
• Equivalent and adequate combination of education and experience