Pharmacovigilance Specialist, Safety data management

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

T he 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 ne wly 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 mana gement activities for company Clinical trial s 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. B enefit-Risk management, Clinical trials and Partner Compliance) , provide inputs and ensure on-time deliver y 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: 3 + years in Pharmacovigilance/Drug Safety working in Safety data management functions with demonstrable hands on experience in c linical trial safety and post-marketing PV activities

Expertise in Safety systems (e.g., Argus, ARISg ); previous experience with Veeva Safety Vault is great advantage

Proven track record working with global Product s 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