Regional Pharmacovigilance Senior Manager

argenx

1d • Remote

About The Position

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Regional Pharmacovigilance Senior Manager will serve as a scientific expert and pharmacovigilance resource to external and internal partners within the region. The Senior Manager will also assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with argenx standards. This position will report directly to the Head of Regional Pharmacovigilance and EU/UK QPPV.

Requirements

• Good presentation skills with the ability to communicate complex issues clearly
• Good planning and organizational skills with ability to manage competing priorities
• Good oral and written communication skills
• 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
• Relevant computer skills, including proficiency with Microsoft Office Suite
• Fluency in written and spoken English
• Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
• At least 7-11 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 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

Responsibilities

• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the harmonization of processes across the regions
• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the management of innovation projects for increasing Regional Team efficiency
• Support the Regional PV Lead in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
• Support the Regional PV Lead in the revision of documents pertinent to Regional PV tasks
• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region
• Contribute to the Pharmacovigilance System Master File (PSMF) data collection in the country/region
• Contribute to increase the visibility of the GPS team/function throughout argenx with focus on the region
• Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed
• Develop relationships with cross functional teams 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
• Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team
• 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 country/region
• Drive Continuous Improvement initiatives as needed
• May perform other tasks as appropriate

Benefits

• This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies.
• It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees