Global Safety Associate – Switzerland (Pharmacovigilance)

Amgen Inc. (IR); Rotkreuz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Total rewards plan

Zusammenfassung

Amgen Inc. (IR) in Rotkreuz, Switzerland, is seeking a Senior Associate Global Safety (Local Safety Switzerland) to support local pharmacovigilance activities and provide safety expertise to the local business.

The role involves data collection, processing, distribution and regulatory submission within safety systems, while ensuring compliance with Swiss legislation and Amgen policies. You will work closely with cross-functional teams in Germany and Austria, and interact with Amgen’s global

Qualifikationen

• University degree in life sciences or a related healthcare discipline.
• Experience in pharmacovigilance, preferably in pharma/biotech.
• Understanding of Swiss PV requirements for post-marketing and trials.
• Experience with PV audits and inspections is an advantage.
• Strong organizational skills and attention to detail.
• Stakeholder management with Commercial, Medical, Regulatory, Quality partners.
• Fluent in English; German fluency required; French/Italian a plus.

Aufgaben

• Support Swiss local pharmacovigilance activities in line with Swiss legislation, Amgen procedures and expectations.
• Maintain current knowledge of and compliance with Swiss safety regulations and work with the Safety Manager to keep local affiliate safety requirements up to date in SOPs, manuals and reporting requirements.
• Support timely and compliant handling of adverse event information, local literature reviews, safety reporting obligations, urgent safety communications and risk minimization activities.
• Assist in the training on adverse event reporting obligations for local staff and/or relevant business partners.
• Support inspection readiness, inspections and internal audits within the role’s area of responsibility.
• Support the alignment with Commercial, Medical, Regulatory, Quality and other affiliate functions that PV requirements are understood and embedded in local activities.

Kenntnisse

Pharmacovigilance

German fluency

English fluency

Stakeholder management

Ausbildung

University degree in life sciences/healthcare

Jobbeschreibung

Amgen Inc. (IR) in Rotkreuz, Switzerland, is seeking a Senior Associate Global Safety (Local Safety Switzerland) to support local pharmacovigilance activities and provide safety expertise to the local business.

The role involves data collection, processing, distribution and regulatory submission within safety systems, while ensuring compliance with Swiss legislation and Amgen policies. You will work closely with cross-functional teams in Germany and Austria, and interact with Amgen’s global