Alvotech

The Pharmacovigilance Manager oversees clinical trial safety activities and manages business partner relationships and compliance for post-marketing programs. They are also responsible for optimizing global PV processes and managing safety systems lifecycle.

Develop and implement global regulatory strategies for post-approval CMC changes and manage the submission of regulatory filings. Serve as a key contact for health authorities and collaborate with cross-functional teams to ensure product supply continuity.

Manage post-approval CMC regulatory filings and evaluate the regulatory impact of manufacturing changes. Collaborate with cross-functional teams to maintain regulatory dossiers and respond to health authority queries.