Senior PV Data & Governance Analyst – Regional

PROSTAFF; Bern; Vor Ort; CHF 80.000 - 110.000; Vollzeit

Zusammenfassung

argenx is seeking a regional pharmacovigilance resource to support the Head of Global Ops, Regions & QM and Regional PV Leads. You will help ensure PV deliverables, systems and processes are compliant across regions.

The role focuses on harmonizing PV activities, monitoring safety requirements, and coordinating with Regulatory, Medical, Quality and Legal teams from Switzerland. This position offers cross-regional exposure and opportunities to drive PV process improvements.

Qualifikationen

• Bachelor’s or Master’s degree in a relevant scientific field (pharmacy, life sciences, etc).
• 5–7 years of experience in pharma/biotech with solid pharmacovigilance expertise.
• Working knowledge of pharmacovigilance regulatory requirements and GVP guidance.
• Experience in preparing, reviewing or maintaining PV documents and procedures.
• Experience with individual case safety report processes and Global Safety Database.
• Experience in PV outsourcing vendor oversight and inspection readiness.

Aufgaben

• Support oversight of PV activities, processes and deliverables.
• Contribute to establishing and maintaining PV systems aligned with GPS standards.
• Monitor and communicate applicable PV regulations and safety requirements.
• Promote awareness of PV obligations across local, regional and global teams.
• Manage company and user profiles in regulatory authority databases and portals.
• Collaborate with Regulatory, Medical, Quality, Legal, and Commercial teams as needed.
• Develop relationships with cross-functional teams for adverse event reporting and safety data collection.
• Oversee processes for case safety report handling and timely processing into the Global Safety Database.
• Support oversight of PV outsourcing vendors and performance monitoring.

Kenntnisse

Planning skills

Communication

Cross-functional collaboration

Pharmacovigilance knowledge

MS Office

English fluency

Ausbildung

Pharmacy degree

Jobbeschreibung

argenx is seeking a regional pharmacovigilance resource to support the Head of Global Ops, Regions & QM and Regional PV Leads. You will help ensure PV deliverables, systems and processes are compliant across regions.

The role focuses on harmonizing PV activities, monitoring safety requirements, and coordinating with Regulatory, Medical, Quality and Legal teams from Switzerland. This position offers cross-regional exposure and opportunities to drive PV process improvements.