Deine Übereinstimmung

Skills

Data collectionPharmacovigilanceCommunicationAttention to detailData processingTrainingCollaborationOrganizational skillsProblem SolvingStakeholder engagementRegulatory Compliance in MedicineSwiss electrical regulations

Sprachen

EnglischDeutschFranzösischItalienisch

Die Stelle

01Support Swiss local pharmacovigilance activities in line with Swiss legislation, Amgen procedures and expectations

02Maintain 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

03Support timely and compliant handling of adverse event information, local literature reviews, safety reporting obligations, urgent safety communications and risk minimization activities

04Assist in the training on adverse event reporting obligations for local staff and/or relevant business partners

05Support inspection readiness, inspections and internal audits within the role’s area of responsibility

06Support the alignment with Commercial, Medical, Regulatory, Quality, Legal, Market Access and other affiliate functions that PV requirements are understood and embedded in local activities

07Support the review of local programs, vendor contracts, websites/social media projects, patient support programs, market research activities and partner arrangements from a PV perspective

Anforderungen

↳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

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

Senior Associate Global Safety (Local Safety Switzerland)