Senior Manager, Safety Operations

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 Senior Manager, Safety Operations will oversee and coordinate operational delivery and staff within Global Patient Safety (GPS) Operations. The incumbent will oversee and coordinate operational delivery by applicable PV vendors. They will align and co-create within the GPS team and argenx in accordance with the argenx vision, strategy and regulatory requirements. They will provide guidance to internal functions and external vendors as required for seamless GPS Operations.

ROLES AND RESPONSIBILITIES

• Oversees and coordinates with safety vendor and GPS teams regarding all aspects of case processing from clinical trials and post marketing

• Coordinates with and supports deliverables with GPS Medical Review roles in relations to case processing

• Coordinates safety / PV deliverables with internal teams (i.e. clinical, medical, or regulatory) and external parties (i.e. HCPs, consumers, or contracted resources)

• Communicates within argenx and with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA)

• Oversees assignments of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication

• Assumes line management responsibilities for Safety Specialist roles as applicable

• Proactively identifies issues and areas for improvement and escalates appropriately

• Proactively engages in the development of new processes and procedures and leads implementation of those

• Performs all activities in compliance with applicable argenx Controlled Procedures and with global and local regulations as applicable

• Performs other tasks as assigned by line manager or Head of GPS Operations

SKILLS AND COMPETENCIES

• Advanced proficiency in medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)

• Proficiency with safety database systems (i.e. Argus) and MedDRA coding

• Advanced computer skills, including proficiency with Microsoft Office including Excel, Power Point, Visio

• Communicates complex issues in an understandable, effective and relevant manner

• Independently manages and prioritizes a variety of tasks for self and team to meet required deadlines

• Makes operational decisions independently or with limited support and has a good understanding of the overall impact and potential risk

• Proactively identifies complex problems, raises issues and proposes solutions constructively

• Has strong ability to successfully collaborate and co-create cross-functionally including managing vendor relationships and leading global teams

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field

• Minimum of 7 years of relevant experience in Safety / Clinical Research / Pharmacovigilance including global pharmacovigilance/drug safety (EU&US)

• Advanced expertise of global (EU/US) pharmacovigilance requirements and practices

• Advanced experience with safety database systems (ARGUS preferred) including workflow management

• Proven experience in interaction with 3rd party vendors

• Extensive experience with the identification of quality issues and evaluation of quality metrics

• Equivalent and adequate combination of education and experience

#LI-Remote