Global Safety Manager (Country Lead)

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.

GLOBAL SAFETY MANAGER (COUNTRY SAFETY LEAD SWITZERLAND)

LIVE

What you will do

In this vital role as a Global Safety Manager/Country Safety Lead Switzerland you will manage Swiss Pharmacovigilance activities and act as the local safety responsible person for Switzerland (Pharmacovigilance responsible Person, medicinal products for human use).

This is a hands-on role for an experienced PV professional who can work independently, manage local safety requirements with confidence, and represents Safety as a trusted partner within the Swiss affiliate. The role holds the PV responsibility for marketed products as well as products in clinical trials, has no direct reports, but requires excellent people skills, strong stakeholder management and the ability to influence without formal authority.

The position works closely with colleagues in Germany and Austria for back-up and alignment and interacts regularly with Amgen’s international safety team worldwide. The job holder will be based in Rotkreuz, Switzerland.

Key Activities:

Manage Swiss local Pharmacovigilance activities in line with Swiss legislation, Amgen procedures and expectations

Act as the local Safety subject matter expert and key PV contact for the Swiss affiliate

Ensure timely and compliant handling of adverse event information, local literature reviews, safety reporting obligations, urgent safety communications and risk minimization activities

Pharmacovigilance responsible Person, medicinal products for human use

Maintain Swiss country-specific safety procedures, local requirements and relevant documentation

Support inspection readiness and act as point of contact for health authority inspections and internal audits within the role’s area of responsibility

Monitor local compliance, identify issues and support appropriate follow-up, including CAPAs where needed

Partner closely with Commercial, Medical, Regulatory, Quality, Legal, Market Access and other affiliate functions to ensure PV requirements are understood and embedded in local activities

Review local programs, vendor contracts, patient support programs, market research activities and partner arrangements from a PV perspective

Coordinate back-up arrangements and operational alignment with Germany and Austria

Represent Switzerland in regional and global safety discussions and contribute to best-practice sharing

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. We are seeking an experienced PV professional who combines strong technical expertise with excellent collaboration and communication skills:

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

Advanced degree or healthcare professional qualification preferred

Significant experience in Pharmacovigilance, preferably in a pharmaceutical or biotech affiliate environment

Experience as Local Safety Officer, Country Safety Lead or equivalent role

Strong understanding of Swiss PV requirements and good knowledge of EU/global PV expectations for both post marketing and for clinical trials

Ability to work independently and manage Swiss PV tasks without day-to-day supervision

Strong stakeholder management skills and confidence working with Commercial, Medical, Regulatory, Quality and other affiliate partners

Ability to explain PV requirements clearly, pragmatically and in a business-relevant way

Experience with audits, inspections, CAPAs and inspection readiness

Strong organizational skills, accountability and attention to detail

Experience with vendor oversight is an advantage

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 critical to patient safety, PV compliance and the reputation of Safety within the Swiss affiliate. We are looking for someone who is technically strong, independent, collaborative and confident, a person who can manage the details while building strong relationships and making Safety a respected partner in the business.

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

APPLY NOW

Objects in your future are closer than they appear. Join us.

CAREERS.AMGEN.COM

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.

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