Senior Associate Global Safety (Local Safety Switzerland)

Amgen; Lavamünd; On-site; EUR 117,000 - 159,000; Full time

Job summary

Amgen seeks a Senior Associate Global Safety (Local Safety Switzerland) based in Rotkreuz to support local pharmacovigilance activities and provide safety expertise to the local business. You will collaborate with German and Austrian teams, manage safety data processing, and ensure Swiss regulatory compliance within Amgen's safety framework.

You will contribute to safety reporting, audits, and inspections, while training staff and aligning PV requirements across affiliates.

Qualifications

• 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 skills would be a plus.

Responsibilities

• 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.

Skills

Pharmacovigilance experience

Swiss PV knowledge

Stakeholder management

English & German fluency

Education

Life sciences/Pharmacy/Medicine degree

Job description

Career Category Safety Job Description 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. Join us.

SENIOR ASSOCIATE GLOBAL SAFETY (LOCAL SAFETY SWITZERLAND)

LIVE

What you will do

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.

Key Activities:

• 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

WIN

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

The ideal candidate will bring:

• 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 skills would be a plus

This role is important to patient safety and Pharmacovigilance compliance in Switzerland, ensuring reliable execution of local safety activities while supporting strong collaboration and embedding Safety expertise across the affiliate.

THRIVE

What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen