Swiss Local Safety Pharmacovigilance Associate

Amgen; Lavamünd; Ibrido; EUR 117.000 - 159.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Pharmacovigilance experience

Swiss PV knowledge

Stakeholder management

English & German fluency

Formazione

Life sciences/Pharmacy/Medicine degree

Descrizione del lavoro

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.