Pharmacovigilance Specialist, Safety data management

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