Senior Scientist, Pharmacovigilance

Specifics of the role: Manage and oversee Clinical trial safety activities and documents preparation and management (e.g. SMP, Protocol, eTMF, IB, etc.) for Alvotech Clinical trials Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.) to execute the assigned activities (SME) Create, maintain and optimize Global Pharmacovigilance processes and ensure compliance with international law and regulations (e.g. FDA, EMA, ICH). Work cross-functionally with other PV department teams and other teams (e.g. Medical affairs) to gather inputs for assigned clinical trial deliverables (e.g. SMP, Protocol, eTMF, IB, etc.) and ensure on-time delivery and compliance. Work cross-functionally with other teams and departments in the company (e.g. Quality, Regulatory, IT, CPD, etc.) and externally with PV service providers and Business partners Deliver trainings on pharmacovigilance processes and standards to company staff and external parties Involved in Audits and Inspections related to Benefit Risk Management activities Minimum education and experience required for the role: Education: Master’s Degree in pharmaceutical sciences …