Director, Regional Pharmacovigilance

🔥 11 minutes ago

🇺🇸 United States – Remote

💵 $192k - $264k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Serve as scientific expert and pharmacovigilance resource to external and internal partners within the country/region • Assess current processes for adherence to local/regional safety regulatory requirements and develop or enhance processes as needed • Act as the main pharmacovigilance point of contact and key partner to country/region leadership • Collaborate with quality, legal, marketing, commercial, communications, and other functions • Establish and maintain the applicable country/region pharmacovigilance system • Support regional process harmonization and innovation projects • Promote awareness of and compliance with pharmacovigilance obligations • Support responses to local pharmacovigilance-related regulatory requests • Communicate global procedures and monitor implementation • Participate in FDA interactions throughout the product life cycle • Oversee US post-authorization requirements • Review US aggregate reports and other pharmacovigilance documents • Serve on the US Labelling Committee and review US labelling • Lead preparation of Pharmacovigilance Agreements • Review documentation related to outsourced activities • Lead PSMF data collection in the country/region when needed • Review documents for non-interventional studies and organized data collection systems • Act as subject matter expert for GPS processes related to organized data collection • Increase GPS team visibility across argenx • Educate cross-functional teams on safety requirements and regulations • Develop relationships related to adverse event reporting and pharmacovigilance activities • Maintain knowledge of US regulations and evolving safety requirements • Identify and communicate pharmacovigilance legislative updates • Participate in GPS audit and inspection readiness and management • Contribute to issue management and implement mitigation action plans • Identify opportunities to align global pharmacovigilance standards • Maintain knowledge of the company product portfolio and disease areas • Contribute to pharmacovigilance KPIs • Escalate issues to GPS leadership as appropriate • Drive continuous improvement initiatives • Perform other tasks as appropriate

🎯 Requirements

• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field • PharmD or MD is a plus • At least 10-15 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities • At least 8 years in pharmacovigilance/drug safety • Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents • Knowledge of the drug development process, GXP quality and compliance requirements • Excellent presentation skills with the ability to communicate complex issues clearly • Excellent planning and organizational skills with ability to manage competing priorities • Excellent oral and written communication skills • Strong ability to motivate, influence, and collaborate with multidisciplinary teams • Ability to work independently and in a global environment • Understanding of safety business processes and systems for the collections of adverse events • Problem solving, conflict resolution and critical thinking skills • Demonstrated ability to author or contribute to complex documents • Proficiency with Microsoft Office Suite • Fluency in written and spoken English • Candidates must be located in the EST time zone

🏖️ Benefits

• Short-term incentives program • Long-term incentives program • Equal consideration for employment without discrimination • Inclusive work environment

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