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Senior Pharmacovigilance Associate

ICON

Senior Pharmacovigilance Associate role managing drug safety deliverables and adverse event reporting for a global healthcare organization. The position involves overseeing pharmacovigilance activities, analyzing safety data, and ensuring regulatory compliance across multiple markets.

Responsibilities

  • Lead collection, evaluation, and processing of adverse event reports per regulatory guidelines
  • Analyze safety data to identify trends and potential safety signals requiring investigation
  • Prepare and submit periodic safety update reports and regulatory documentation
  • Collaborate with medical teams to assess clinical relevance of adverse events
  • Maintain pharmacovigilance database integrity and ensure data management compliance

Requirements

  • Bachelor's degree in scientific or healthcare-related discipline
  • Extensive pharmacovigilance or drug safety experience with regulatory knowledge
  • Proficiency in pharmacovigilance databases and Microsoft Office Suite
  • Strong analytical skills for complex data interpretation and signal detection
  • Demonstrated ability to manage adverse event reporting independently
  • Excellent cross-functional communication and collaboration abilities
  • Willingness to travel approximately 15% as required
Oferta pracy dodana 23 dni temu