Principal Specialist Pharmacovigilance Quality

Alvotech

Website: alvotech.com
Job details:
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.

Overview Of Job Role

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:

This role primarily serves as a direct quality partner with relevant subject matter experts in iCMR to ensure integration of quality advisory and quality oversight in pharmacovigilance system. Reporting to Clinical and Medical Quality (CMQ) within Alvotech corporate quality unit, the incumbent will be responsible for deploying of risk-proportionate quality assurance and oversight tactics product-level as well as in other strategic initiatives in remit of CMQ, as relevant to innovation in iCMR and CMQ.

Scope and responsibility

• Contribute to PV system transformation and development initiatives
• Support PV / PADE inspection readiness activities
• Participate in coordination of inspections and audits
• Conduct quality evaluation of select internal PV records, pharmacovigilance service providers, and business partners.
• Support identification of procedural gaps and risk management initiatives
• Engage with PV teams in complex non-compliance investigations; approve investigations into noncompliance
• Manage Veeva Vault Quality workflows
• Contribute to inspections and audits coordination and follow-up activities.
• Approve CAPAs, effectiveness check and objective evidence.
• Manage CMQ-owned documents and records in Veeva.
  
  

Job Requirements

• Pharmacist or university degree in healthcare, life sciences or equivalent.
• Minimum 5 years of combined experience in PV and Quality roles in biopharmaceutical companies that have marketed products in the USA.
• Minimum 3 years of multiple exposure to PADE / PV inspections conducted by FDA / EU Member states authorities.
• High digital acumen and experience in working with Veeva Quality and Safety Vaults; additional experience with other safety databases or data migration is preferred.
• Excellent communication, writing, and presentation skills in English.
• Advance understanding of applicable US FDA, ICH and EMA regulations governing pharmacovigilance.

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