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) Specialist will be responsible and accountable for all assigned Clinical Safety and post-marketing PV activities. The Pharmacovigilance Specialist will be part of the newly developed, lean and effective, 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 specialist will also be involved in development of the team’s processes, PV systems development and lifecycle management. The PV specialist will work independently, own assigned activities and ensure regulatory compliance.

Scope and responsibility
- Work on assigned Clinical Safety and post-marketing PV activities (e.g. ICSR/SAE management and regulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)
- Participate in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.)
- 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. Benefit-R

📌 Pharmacovigilance Specialist, Safety data management (India)
🏢 Alvotech
📍 India