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 productive, 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. Ben

📌 Pharmacovigilance Associate, Safety Data Management (India)
🏢 Alvotech
📍 India