Global Safety Manager (Country Lead)

Position

Vollzeit

Festanstellung

Mid

Gesundheitswesen

Konditionen

Switzerland - Rotkreuz

Vor Ort

Anforderungen

5+ J. Erfahrung

Bachelor

EU/EFTA-Bewilligung

Sprachen

Englisch C1

Deutsch B2

Französisch

Italienisch

Beschreibung

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.

Aufgaben

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
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

Anforderungen

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

Vorteile

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

Unternehmen

Amgen

Biotechnology

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.