GPS Regional Pharmacovigilance Manager

argenx SE; Oost-Vlaanderen; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Incentives program

Résumé du poste

argenx SE is seeking an experienced Pharmacovigilance Lead to support the Head of Global Ops, Regions & QM and Regional PV Leads. You will help harmonize processes, ensure compliance with regional and global PV requirements, and oversee safety data activities across regions.

The role requires strong collaboration with Regulatory, Medical, Quality and Legal teams, plus experience in managing vendors and audit readiness. Based in Belgium/Switzerland or similar region.

Qualifications

• Bachelor's or Master's degree in life sciences or related field.
• Solid experience in pharmacovigilance or drug safety.
• Working knowledge of pharmacovigilance regulatory requirements and GxP.

Responsabilités

• Support oversight of Regional PV activities and deliverables.
• Develop and maintain regional PV processes aligned with GPS standards.
• Monitor applicable PV legislation and safety requirements impacting PV activities.
• Promote awareness of PV obligations and ensure regulatory compliance.
• Maintain company and user profiles in regulatory databases and portals.
• Collaborate with Regulatory, Medical, Quality, Legal and other teams.
• Support management of adverse event reporting and safety data collection.
• Oversee PV outsourcing vendors and ensure quality and contractual alignment.
• Participate in GPS audit and inspection readiness activities.
• Maintain knowledge of product portfolio and development landscape.
• Contribute to continuous improvement of regional PV efficiency.

Connaissances

Pharmacovigilance

Regulatory compliance

Cross-functional collaboration

Safety data management

GVP knowledge

English fluency

Formation

Bachelor's or Master's degree in life sciences or related field

Description du poste

Company Overview

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.

Purpose of the Function

Support the Head of Global Ops, Regions & QM and Regional PV Leads in ensuring that applicable pharmacovigilance (PV) deliverables, systems and processes are implemented, maintained and continuously improved in compliance with global, regional and local regulatory requirements. Serve as a regional pharmacovigilance resource for internal and external stakeholders, contributing to process harmonization, inspection readiness, safety data oversight and consistent application of argenx standards across regions. Reporting to: Head of Global Ops, Regions & QM

Roles and Responsibilities

• Support the Head of Global Ops, Regions & QM and Regional PV Leads in the oversight, harmonization and maintenance of Regional PV activities, processes and deliverables.
• Contribute to the establishment and maintenance of the applicable pharmacovigilance system specific to the assigned country or region, ensuring alignment with global GPS processes and standards.
• Support in the monitoring and communicate applicable pharmacovigilance legislation, regulatory expectations and safety requirements that may impact Regional PV activities or the broader GPS function.
• Promote awareness of pharmacovigilance obligations and support compliance with local, regional and global requirements.
• Support the management and maintenance of company and user profiles in applicable regulatory authority databases and portals, as relevant to Regional PV activities.
• Collaborates with Regulatory, Medical, Quality, Legal, Commercial and other teams, as needed.
• Develop and maintain relationships with cross-functional teams as they relate to adverse event reporting, safety data collection and other PV activities.
• Support oversight of individual case safety report processes, including the management, quality and timely processing of cases into the Global Safety Database, in collaboration with relevant GPS teams and partners.
• Support the oversight and operational management of pharmacovigilance outsourcing vendors, including performance monitoring, issue escalation, quality follow-up and alignment with contractual and procedural requirements.
• Participate in GPS audit and inspection readiness, support and management together with GPS Quality Management and Quality teams.
• Maintain knowledge of the company product portfolio, disease areas, marketed products and products in development.
• Contribute to continuous improvement and innovation initiatives aimed at increasing Regional PV efficiency and process maturity.
• Perform other tasks as appropriate and requested.

Skills and Competencies

• Good planning and organizational skills.
• Good oral and written communication skills, with the ability to clearly communicate complex issues to different audiences.
• Demonstrated ability to collaborate with and work effectively across multidisciplinary and global teams.
• Understanding of safety business processes, adverse event collection and pharmacovigilance systems.
• Problem-solving skills.
• Relevant computer skills, including proficiency with Microsoft Office Suite.
• Fluency in written and spoken English.
• Other languages are an asset.

Education, Experience and Qualifications

• Bachelor's or Master's degree in pharmacy, nursing, healthcare, life sciences or another relevant scientific field.
• Approximately 5 to 7 years of experience in the pharmaceutical or biotech industry, regulatory authorities or related environment, with solid experience in pharmacovigilance or drug safety.
• Working knowledge of pharmacovigilance regulatory requirements, GVP guidance documents and applicable GxP quality and compliance expectations.
• Experience in the preparation, review or maintenance of pharmacovigilance documents, procedures, work instructions or related controlled documents.
• High Experience with individual case safety report processes and the management of cases into a Global Safety Database.
• Experience in the oversight or management of pharmacovigilance outsourcing vendors, including operational performance, quality follow-up and issue management.
• Experience in audit and inspection readiness, inspection support or participation in pharmacovigilance inspections is preferred.
• Knowledge of regional pharmacovigilance operations, safety data collection and cross-functional PV processes is preferred.
• To be considered for this role, candidates must be based in Belgium or Switzerland.

Benefits

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

Compensation

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.

Equality and Diversity

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

Company Background

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment.

Locations

argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam.

Privacy and Contact

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