About the Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and 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.
iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:
Overview of Job Role
The Pharmacovigilance (PV) Associate will be responsible for all assigned Clinical Safety and post-marketing PV activities. The PV Associate will be part of the newly developed, lean and efficient, Global Safety Data Management team, reporting to the Safety Data Management Director. The focus of this role will be on Safety data management activities for company Clinical trials as well as post-marketing programs. The PV Associate will also be involved in development of the team’s processes, and development and lifecycle management of PV systems. The PV Associate will work on assigned tasks and activities and ensuring regulatory compliance and compliance with company processes.
Scope and responsibility
Work on assigned Clinical Safety and post-marketing PV tasks (e.g. ICSR/SAE management, Regulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)
Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.)
Involved in maintaining and optimizing Global Pharmacovigilance processes and ensuring compliance with international law and regulations (e.g. FDA, EMA, ICH).
Work cross-functionally with other PV department teams and other teams (e.g. Benefit-Risk management, Clinical trials and Partner Compliance), provide inputs 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 Safety Data Management activities
Job requirements
Education: Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences
Experience: 2+ years in Pharmacovigilance/Drug Safety working in Safety data management functions with demonstrable hands on experience in clinical trial safety and post-marketing PV activities
Expertise working in Safety systems (e.g., Argus, ARISg); previous experience with Veeva Safety Vault is great advantage
Proven track record working with global Products and Clinical trials
Previous experience with biologic and combination products is an advantage
Detailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)
Mature self-organizational, time-management and interpersonal skills
Excellent communication skills, maintains a positive, result oriented work environment
Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.
Willingness to travel internationally, as required
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Alvotech is a biopharmaceutical company focused on the development and manufacturing of biosimilar medicines. They aim to provide affordable and accessible biologic treatments to patients worldwide.