ID EXISTS
POS 5172
Status 5
DJM 1

Global Safety Lead

Beschreibung: For one of our German pharma clients we are seeking freelance support as: Global Safety Lead (M/F/D)
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Tasks:
  • Managing and overseeing the safety profiles of marketed products at a global level (signaling, periodic safety report compilation, risk management, authority response to safety questions etc)
  • Defining the safety strategy for development compounds
  • Risk mitigation
  • Providing Safety input in relevant development documents (IB, ICF, protocol, SAP etc), DSUR compilation
  • Representing safety in clinical development teams
  • Regular safety surveillance/signaling for marketed products
  • Provision of medical input in periodic safety reports/analyses
  • Chairing the Safety Management team as required
  • Responding to requests regulatory authorities regarding safety
  • Defining safety strategy and provision of safety input in clinical dev. Documents
  • Providing safety input in briefing books for discussion with health authorities, input in safety sections of dossiers
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Qualification:
  • Start: asap, latest January 22 // Duration: 12 months // Capacity: ideally 5 days/week
  • Physician
  • Profound experience within Pharmacovigilance (min. 5 years)
  • Extensive knowledge of the tasks described above
  • Profound experience with Argus database
  • Must Have: Business fluency in English, German is a plus
Bemerkungen: WANTED: Global Safety Lead (M/W/D). Bitte nehmen Sie Kontakt auf: +49 89 1890998 42 oder manuel.maiwald@k-recruiting.com Skills: Drug Safety / Pharmacovigilance, English
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Interesse geweckt?
Auf geht's!
Beginn: asap, latest January 22
Laufzeit: 12 months
Einsatzort: remote
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