Safety Operations Manager, Global Patient Safety

This is a fully remote position, open to applicants in Belgium, +2 more countries.

📋 Description

• Manage the operational execution and personnel within Global Patient Safety Operations, aligning with GPS vision, strategy, and regulatory standards.

• Direct internal teams and external partners to ensure smooth GPS Operations.

• Supervise and coordinate safety vendor and GPS teams for case triage, processing, expedited reporting, and aggregate reporting.

• Collaborate with and assist the GPS GSL team with deliverables concerning case processing.

• Work together with clinical, medical, regulatory, and other internal teams, as well as healthcare professionals, consumers, and contracted services.

• Liaise with argenx, business partners, and distributors about Pharmacovigilance Agreements and Safety Data Exchange Agreements.

• Oversee the assignment of tasks to Safety Specialists and ensure timely monitoring of GPS communications.

• Recognize issues and improvement opportunities, escalating them as needed.

• Create new processes and procedures, leading their execution.

• Conduct activities in accordance with argenx Controlled Procedures and all relevant global and local regulations.

• Carry out additional tasks as assigned by the line manager or Head of GPS.

⛳️ Requirements

• In-depth understanding of medical terminology, pharmacovigilance processes, and applicable global regulations, including those of the EU, US, and Japan.

• Strong background and experience in post-marketing pharmacovigilance and global reporting standards.

• Proficiency in safety database systems, including Argus, along with MedDRA coding.

• Advanced computer skills, including Microsoft Office Suite, Excel, PowerPoint, and Visio.

• Exceptional written and verbal communication skills in English.

• Experience in participating in Health Authority inspections is a plus.

• Bachelor’s or Master’s degree (or local equivalent) in nursing, healthcare, life sciences, or a related field.

• At least 5 years of relevant experience in Safety, Clinical Research, or Pharmacovigilance.

• Minimum of 7 years of relevant experience in global pharmacovigilance/drug safety within the EU and US.

• A suitable combination of education and experience is acceptable.

• Advanced knowledge of global EU/US pharmacovigilance requirements and practices.

• Extensive experience with safety database systems, preferably ARGUS, including workflow management.

• Demonstrated experience working with third-party vendors.

• Proven ability to identify quality issues and assess quality metrics.

• Must reside in Belgium, Switzerland, or the US (EST time zone).

🏝️ Benefits

• Short-term incentives program.

• Long-term incentives program.

• Inclusive work environment.

• Equal opportunity for employment without discrimination.