About the role
About the Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively ondevelopmentand manufacturing of high-quality biosimilar medicines.
Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.
iCMRis launching an ambitious and exciting project aimed at modernizing andoptimizingthe departmental operating model. As part of this project, we are recruiting for the following position:
Overview ofJobRole
ThePharmacovigilance(PV)Specialistwill be responsibleand accountableforallassignedClinical Safetyand post-marketingPVactivities. The PharmacovigilanceSpecialistwill be part of the newlydeveloped,leanand efficient,Global Safety Data Management team,reporting to theSafety Data ManagementDirector.The focusof this rolewill be onSafety data management activities forcompanyClinical trialsas well aspost-marketing programs.The PVspecialist willalsobe involved indevelopmentof theteam’s processes,PVsystemsdevelopmentand lifecycle management.The PVspecialistwillwork independently,own assignedactivities and ensure regulatory compliance.
Scope and responsibility
Work on assignedClinical Safetyand post-marketingPVactivities(e.g.ICSR/SAE management and regulatory submissions,Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD,etc.)
ParticipateinSafety systemssetup and lifecycle management (e.g.configuration, validation, system lifecycle management, etc.)
Create,maintainandoptimizeGlobal Pharmacovigilance processes and ensure compliance with international law and regulations (e.g.FDA, EMA, ICH).
Work cross-functionally with other PV department teams andother teams(e.g.Benefit-Risk management, Clinicaltrialsand Partner Compliance),provideinputsandensureon-timedeliveryand 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 toSafety Data Managementactivities
Job requirements
Education: Master’s Degree inpharmaceutical sciences or related fields – medicine, pharmacy, life sciences
Experience: 3+ years in Pharmacovigilance/Drug Safetyworking in Safety data managementfunctionswith demonstrablehands onexperienceinclinical trial safetyand post-marketing PV activities
ExpertiseinSafety systems (e.g., Argus,ARISg);previousexperience with Veeva Safety Vault is great advantage
Proventrack recordworkingwith global ProductsandClinical trials
Previousexperience with biologic and combination products is an advantage
Detailed knowledge of PV processes, directives,regulationsand international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)
Mature self-organizational, time-management and interpersonal skills
Excellent communication skills,maintainsa positive, result oriented work environment
Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.
Willingness to travel internationally, asrequired