Position Summary

The Senior Pharmacovigilance Specialist is part of Medical Affairs & Pharmacovigilance Operations department and is responsible for global Pharmacovigilance activities in Xellia.

Key Responsibilities

• Act as a Pharmacovigilance Responsible Person (PVRP) on behalf of Xellia.
• Responsible for Xellia overall global Pharmacovigilance activities (including but not limited to territories of the European Union (EU), the United Kingdom (UK), the United States (USA), Middle East and North Africa (MENA), Latin America (LATAM), China and other international markets).
• Timely communication with the Pharmacovigilance Service Provider (PSP), distributors, in-licensing partners, and authorities in relation to PV issues.
• Handling all incoming safety related information that Xellia is made aware of (this information is forwarded to the PSP, in-licensing partners and/or distributors).
• Logging Adverse Events (AE)/Adverse Drug Reactions (ADRs) in Information Request Management System (IRMS).
• Monthly reconciliation of PV documentation with PSP, distributors, in-licensing partners, manufacturers and relevant internal Xellia departments.
• Review of documents prepared by PSP:
  • Signal detection reports
  • Pharmacovigilance System Master File (PSMF) updates
  • Company Core Safety Information (CCSI)
  • Risk management plans (RMP)
  • Periodic Safety Update Report (PSUR) and Periodic Adverse Drug Experience Report (PADER)
• Overview of compliance metrics reports (timely submissions).
• Preparation of quality management review summary.
• Drafting contracts related to PV, including but not limited to Safety Data Exchange Agreements (SDEAs).
• Performing Risk Assessment of PV partners.
• Tracking of product labelling sent to the PSP.
• Implementation and distribution of Risk Minimization Activities.
• Preparation and maintaining of PV Standard Operating Procedures (SOPs) to be in line with latest guidelines, Xellia scope of work and territories covered.
• Participation in Module 1 documents preparation related to PV.
• Management of PV documents’ lifecycle in electronic database related to PV documentation (MyProcess).
• Preparation and coordination of PV audits as a Subject Matter Expert (SME) together with Lead Auditor and audit report review.
• Screening and selection of new Pharmacovigilance vendors in collaboration with internal stakeholders on territories where this is required.
• Creation of Annual Pharmacovigilance training and Pharmacovigilance Business Continuity Plan.
• Creation and maintenance of PV approved vendor list.

What we expect

• MSc or equivalent in relevant field (medical, pharmacy, biology, biotechnology)
• 3-5 years of relevant experience from Pharma industry - Pharmacovigilance
• Communication skills in a global environment
• Stakeholder management
• Analytical thinking
• Attention to detail and the ability to work independently
• Fluent in Hungarian and English (spoken and written)

What We Offer

• Competitive compensation and benefit package
• „Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment
• Home office opportunity

Xellia Pharmaceuticals is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines, we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark, we operate manufacturing sites in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, with R&D and commercial operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years, we are driven by purpose and progress.

With more than 1100 employees, our impact starts from within. We offer a workplace where ideas, curiosity, and initiative thrive, and where your role evolves with your ambition. Instead of rigid structures, we provide real responsibility, freedom to explore, and support to grow. Together, we shape not only the future of our company and the development of our people, but also the health of communities worldwide.

Further information about Xellia can be found at: www.xellia.com
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