Regional Pharmacovigilance Manager – Global Ops

argenx; Zürich; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Incentives program

Zusammenfassung

argenx in Switzerland is seeking a Pharmacovigilance professional to support regional PV activities, ensuring alignment with global GPS processes and regulatory requirements. You will contribute to safety data oversight, external partnerships, and audit readiness.

The role focuses on maintaining PV systems, coordinating with Regulatory, Medical, Quality and Legal teams, and driving continuous improvement within a global, fast‑growing biotech environment.

Qualifikationen

• Strong planning and organizational abilities.
• Clear oral and written communication across audiences.
• Demonstrated collaboration across multidisciplinary and global teams.
• Understanding of safety business processes and pharmacovigilance systems.
• Proven problem‑solving skills.
• Proficient with Microsoft Office Suite.
• Fluent in written and spoken English; additional languages are an asset.

Aufgaben

• Support the Head of Global Ops, Regions & QM and Regional PV Leads in overseeing, harmonizing and maintaining Regional PV activities, processes and deliverables.
• Contribute to establishing and maintaining the applicable pharmacovigilance system for the assigned country or region, aligned with GPS processes and standards.
• Monitor and communicate regulatory expectations and safety requirements affecting Regional PV activities or the GPS function.
• Promote awareness of PV obligations and support compliance with local, regional and global requirements.
• Assist in maintaining company and user profiles in regulatory databases and portals as relevant to Regional PV activities.
• Collaborate with Regulatory, Medical, Quality, Legal, Commercial and other teams as needed.
• Develop relationships with cross-functional teams related to adverse event reporting and safety data collection.
• Support management of individual case safety report processes and timely data entry into the Global Safety Database.
• Oversee pharmacovigilance outsourcing vendors, ensuring performance, quality follow-up and contractual alignment.
• Participate in GPS audit and inspection readiness with GPS Quality Management and Quality teams.
• Maintain knowledge of the product portfolio, disease areas and products in development.
• Contribute to continuous improvement initiatives to increase PV efficiency and process maturity.
• Perform other tasks as appropriate.

Kenntnisse

Planning

Communication

Collaboration

Safety processes

Problem solving

MS Office

English fluency

Ausbildung

Bachelor’s or Master’s degree in pharmacy, life sciences or related field

Jobbeschreibung

argenx in Switzerland is seeking a Pharmacovigilance professional to support regional PV activities, ensuring alignment with global GPS processes and regulatory requirements. You will contribute to safety data oversight, external partnerships, and audit readiness.

The role focuses on maintaining PV systems, coordinating with Regulatory, Medical, Quality and Legal teams, and driving continuous improvement within a global, fast‑growing biotech environment.