Senior Associate Global Safety (Local Safety Switzerland)
Poste
Temps plein
Permanent
Mid
Santé
Modalités
Switzerland - Rotkreuz, Zoug
Sur site
Exigences
Bachelor
Permis UE/AELE
Compétences
Data collectionPharmacovigilanceCommunicationAttention to detailData processingTrainingCollaborationOrganizational skillsProblem SolvingStakeholder engagementRegulatory Compliance in MedicineSwiss electrical regulations
Langues
Anglais
Allemand
Français
Italien
Responsabilités
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
Exigences
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 escalate 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
Avantages
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
Entreprise
Amgen
Biotechnology
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