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.
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