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