Senior Global Safety Associate - Local PV Switzerland

Amgen SA; Rotkreuz; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Amgen SA in Rotkreuz, Switzerland is seeking a Senior Associate Global Safety (Local Safety Switzerland) to support local pharmacovigilance activities, ensure Swiss safety compliance, and contribute safety expertise to cross-functional teams. You will handle adverse events, literature reviews, and safety reporting obligations while collaborating with an international safety network.

You will coordinate training for staff, support inspections, and align PV requirements with Commercial, Medical,

Qualifikationen

• Experience in pharmacovigilance, preferably in a pharmaceutical or biotech affiliate environment.
• Practical understanding of Swiss PV requirements for post marketing and clinical trials.
• Experience with Pharmacovigilance Audits and Inspections is an advantage.
• Strong organizational skills, accountability and attention to detail.
• Stakeholder management with Commercial, Medical, Regulatory and Quality partners.
• Ability to identify and elevate safety issues with problem-solving abilities.

Aufgaben

• Support Swiss local pharmacovigilance activities in line with Swiss legislation and SOPs.
• Maintain compliance with Swiss safety regulations and local safety requirements.
• Assist in handling adverse event information, literature reviews and safety reporting obligations.
• Support training on adverse event reporting obligations for local staff and partners.
• Support inspection readiness, inspections and internal audits within the role’s area.
• Collaborate with Commercial, Medical, Regulatory, Quality and other affiliate functions on PV requirements.
• Review local programs, vendor contracts and partner arrangements from a PV perspective.

Kenntnisse

Pharmacovigilance

Safety reporting

Regulatory knowledge

Stakeholder management

Attention to detail

Ausbildung

University degree in life sciences, pharmacy, medicine, veterinary medicine or another relevant scientific/healthcare discipline

Jobbeschreibung

Amgen SA in Rotkreuz, Switzerland is seeking a Senior Associate Global Safety (Local Safety Switzerland) to support local pharmacovigilance activities, ensure Swiss safety compliance, and contribute safety expertise to cross-functional teams. You will handle adverse events, literature reviews, and safety reporting obligations while collaborating with an international safety network.

You will coordinate training for staff, support inspections, and align PV requirements with Commercial, Medical,