Pharmacovigilance Specialist (f/m/d)

☞ GULP – experts united

Ver: 167

Dia de atualização: 18-10-2024

Localização: Ingelheim am Rhein Rhineland-Palatinate

Categoria: Gestão executiva Produção / Operação

Indústria: Staffing Recruiting

Posição: Entry level

Tipo de empregos: Full-time

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Conteúdo do emprego

Einleitung

Was Wir Bieten

Time for change – time for a new job! You are a Pharmacovigilance Specialistand looking for a new professional challenge? Then stop searching! We offer the job you are looking for: a secure job, fair compensation and exciting new tasks at an attractive internationalcompany in the Rhine-Main area. Apply online now! We welcome applications from all suitably qualified persons regardless of any disabilities.

  • Option of permanent employment with our business partner
  • Extensive social benefits, incl. Christmas and holiday bonuses
  • Up to 30 days vacation per year
  • Free online courses, e.g. "German as a foreign language"

Ihre Aufgaben

  • Active participation in the preparation and finalization of Safety Update Reports (SUR) for submission
  • Stock keeping unit (SKU) mapping reviews linked to sales data
  • Manual calculation of doses sold and percentage incidences of adverse event reports
  • Data integrity - pulling case line listings and performing data quality checks on cases in the PV database within the scope of SUR preparation
  • Extraction and adaptation of SUR templates according to working instructions
  • Reviewing regulatory information to ascertain PV related safety actions or requesting regulatory information from product responsible Regulatory Affairs (RA) managers
  • Uploading and finalization of reports on shared portal
  • Liaising and working closely with colleagues in RA and local PV teams to ensure the timely transmission SURs to competent authorities
  • Support with the preparation of PV documents (e.g., Requests for PV Information (RPI), PV statements, Product Benefit Risk Evaluation Reports) and archiving all PV related communications
  • Miscellaneous – pro-active collaboration with other PV Specialist colleagues on various tasks

Ihr Profil

  • Associate degree in life sciences
  • Experience working in a GMP/compliance environment subject to authority inspections and knowledge of legal PV requirements and PV report preparation
  • Fluent in spoken and written English, fluency in German is an asset
  • Good Understanding of MS Office tools and Electronic document management systems
  • Residence in Germany

Firmenbeschreibung
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Data limite: 02-12-2024

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