Senior Associate Global Safety; Local Safety

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of.

LIVE

In this vital role as a Senior Associate Global Safety (Local Safety Switzerland) you will support local pharmacovigilance activities in Switzerland and support provision of safety expertise to the local business. You will conduct core safety activities including data collection, processing, distribution and regulatory submission, based on appropriate training and assigned roles within the safety database and related systems. You will maintain compliance with Swiss legislation, Amgen policies and procedures, support the Safety Manager across the full range of local safety activities, and contribute safety expertise to local medical teams and cross‑functional activities.

The ability to identify, prioritize and elevate safety issues is important. The role works closely with colleagues in Germany and Austria and interacts regularly with Amgen’s international safety team worldwide. The job holder will be based in Rotkreuz, Switzerland.

• 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, Legal, Market Access and other affiliate functions that PV requirements are understood and embedded in local activities
• Support the review of local programs, vendor contracts, websites/social media projects, patient support programs, market research activities and partner arrangements from a PV perspective

We are all different, yet we all use our unique contributions to serve patients. We are seeking a pharmacovigilance experienced individual who combines practical knowledge of pharmacovigilance with strong collaboration, communication and problem‑solving skills.

• University degree in life sciences, pharmacy, medicine, veterinary medicine or another relevant scientific/healthcare discipline
• Experience in pharmacovigilance, preferably in a pharmaceutical or biotech affiliate environment
• Practical understanding of Swiss PV requirements for both post marketing and for clinical trials
• Experience with Pharmacovigilance Audits and Inspections is an advantage
• Strong organizational skills, accountability and attention to detail
• Stakeholder management skills and confidence working with Commercial, Medical, Regulatory, Quality and other affiliate partners
• Ability to identify, prioritize and elevate safety issues, with sound problem‑solving abilities
• Confident in handling core operational safety activities (when trained)
• Excellent written and verbal communication skills in English as well as fluency in German;
  French and/or Italian language…