Senior / Pharmacovigilance Specialist

Position summary

Pharmacovigilance Specialist processes, clarifies, and distributes safety reports and data in close collaboration with medical and investigational site personnel. In his/her assigned capacity contributes to pharmacovigilance system maintenance, company quality management and regulatory compliance as well as supports company product and project teams.

Key Activities and Responsibilities

  • Processing of Serious Adverse Events, Adverse Events of Special Interest and pregnancy reports in accordance with company and department standards
  • Communication with medical personnel and investigational sites
  • Safety narratives preparation and quality check
  • Reconciliation of safety information between databases and discrepancy management
  • Supporting preparation, distribution and submission of expedited and periodic reports in accordance with applicable regulatory requirements
  • Maintenance of TMF safety section and pharmacovigilance compliance documentation in assigned projects
  • Supporting product and project teams with pharmacovigilance expertise and data
  • Contributing to quality system processes such as CAPA, change control, risk analysis etc.

Competences, Skills and Qualification

  • Bachelor’s degree
  • At least 2 years’ experience in pharmaceutical or biotechnology industry
  • Working knowledge of internationally recognized pharmacovigilance standards and regulations (e.g. ICH GCP, ICH E2A, ICH E2F, Directive 2001/20/EC, CT-3, etc.)
  • Detail-oriented and able to work in multi-disciplinary team
  • English spoken and written fluency
  • Experience of working with safety database(s)
  • Training in MedDRA coding, EMA Eudravigilance database systems, electronic trial master file and quality management system are of advantage
  • Proficiency in Microsoft office applications (Word, Excel, Outlook)

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