Global Safety Manager (Country Lead)

Amgen seeks a Senior Global Safety Manager (Country Lead) in Rotkreuz, Switzerland, to oversee local pharmacovigilance activities, ensure regulatory compliance, and serve as the primary safety contact for the Swiss affiliate.

This position serves as the designated local safety lead for Switzerland, managing pharmacovigilance operations for both marketed products and clinical trial candidates. The role ensures strict adherence to Swiss legislation while collaborating with international safety teams and regional partners in Germany and Austria to maintain operational alignment and backup coverage.

Responsibilities

• Oversee daily pharmacovigilance operations in Switzerland, ensuring full compliance with local laws and internal company standards.
• Serve as the primary safety expert and main point of contact for the Swiss affiliate regarding all safety-related matters.
• Process adverse event reports, conduct local literature reviews, manage safety communications, and execute risk minimization strategies in a timely manner.
• Maintain and update country-specific safety protocols, documentation, and local regulatory requirements.
• Prepare for and support health authority inspections and internal audits, acting as the main liaison during these events.
• Monitor local compliance levels, identify potential issues, and implement corrective actions (CAPAs) as necessary.
• Collaborate with cross-functional teams including Commercial, Medical, Regulatory, Quality, Legal, and Market Access to integrate pharmacovigilance requirements into local business activities.
• Evaluate local programs, vendor contracts, patient support initiatives, and market research from a safety perspective.
• Coordinate backup arrangements and operational alignment with colleagues in Germany and Austria.
• Represent the Swiss affiliate in regional and global safety forums, contributing to best-practice sharing and strategic discussions.

Requirements

• University degree in life sciences, pharmacy, medicine, veterinary medicine, or a related scientific/healthcare field.
• Extensive experience in pharmacovigilance, ideally within a pharmaceutical or biotech affiliate setting.
• Proven track record as a Local Safety Officer, Country Safety Lead, or in a similar capacity.
• Deep understanding of Swiss pharmacovigilance regulations and familiarity with EU/global standards for post-marketing and clinical trial safety.
• Ability to work autonomously and manage Swiss pharmacovigilance tasks without daily supervision.
• Strong stakeholder management skills, with confidence in engaging Commercial, Medical, Regulatory, Quality, and other affiliate partners.
• Capacity to explain pharmacovigilance requirements clearly, pragmatically, and in a business-relevant manner.
• Experience with audits, inspections, CAPAs, and inspection readiness.
• Strong organizational skills, accountability, and attention to detail.
• Excellent written and verbal communication skills in English and fluency in German.

Nice to have

• Advanced degree or healthcare professional qualification is preferred.
• Experience with vendor oversight is an advantage.
• French and/or Italian language skills would be a plus.

What the company offers

• Extensive opportunities for professional growth, learning, and mobility within the global organization.
• A diverse and inclusive community where employees are encouraged to share ideas and take action.
• A comprehensive Total Rewards Plan including health, finance and wealth, work/life balance, and career benefits.

About the company

Amgen is a global collaborator dedicated to serving patients by researching, manufacturing, and delivering innovative products to over 10 million individuals worldwide. The company is committed to supporting the professional and personal growth and well-being of its teammates, fostering a culture of care and inclusion.

• Shared mission to serve patients.
• Global collaboration and innovation.
• Support for teammate growth and well-being.
• Diverse and inclusive community.