Safety Operations Manager, Global Patient Safety

PURPOSE OF THE FUNCTION

• Oversees operational delivery and staff within Global Patient Safety (GPS) Operations, in accordance with the GPS vision, strategy and regulatory requirements.
• Interacts with and provides guidance to internal functions and external vendors as required for seamless GPS Operations

REPORTING LINE

• Director, Global Patient Safety Operations

ROLES AND RESPONSIBILITIES

• Oversees and coordinates with safety vendor and GPS teams regarding case triage and processing, expedited and aggregate reporting·
• Coordinates with and supports deliverables with GPS GSL team in relations to case processing·
• Collaborates with other internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) regarding safety related deliverables and processes·
• Communicates within argenx and with business partners or distributors regarding deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).·
• Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS communication·
• 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
  

SKILLS AND COMPETENCIES

• Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
• A strong background/experience of post-marketing pharmacovigilance and knowledge of global reporting requirements
• 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
• Manages and prioritizes a variety of tasks for self and team to meet required deadlines
• Makes operational decisions with limited supervision and has a good understanding of the overall impact and potential risk
• Identifies complex problems, raises issues and proposes solutions constructively
• Proven ability to communicate effectively and collaborate successfully across functions and with vendors
• Advanced communication in written and spoken English required
• Experience of active participation in Health Authority inspections would be an advantage

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
• Minimum of 5 years of relevant experience in Safety / Clinical Research / Pharmacovigilance
• At least 7 years of relevant experience in global pharmacovigilance/drug safety (EU&US)
• Equivalent and adequate combination of education and experience
• 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
• Proven experience with the identification of quality issues and evaluation of quality metrics

Candidates must be located in Belgium, Switzerland or US (EST time zone) to be considered for this role.

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Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.

This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.