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Pharmacovigliance specialist (m/w/d)

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Zusammenfassung

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Job Details

Ihre Aufgaben

  • Active participation in the preparation and finalization of Safety Update Reports, e.g. contributing to the creation and completion of reports that provide updates on the safety of a drug or medical device, e.g. calculating sales/incidence and checki
  • Support with the preparation of PV documenta, e.g., Requests for PV Information, Pharmacovigilance Safety Master File, PV statements, Product Benefit Risk Evaluation Reports and archiving all PV related communications
  • Creation of workflows used to track PV related activities by designing and implementing processes that help track and manage various activities related to pharmacovigilance, including follow-up updates
  • Support with annual sales submission to competent authorities as required
  • Miscellaneous - pro-active collaboration with other PV Specialist colleagues on various tasks, e.g., compliance monitoring - KPls/Metrics and handling other tasks as assigned by supervisor or PV management

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